Hypoxia chamber of the CRU

Clinical Research Unit

The Clinical Research Unit on Campus Buch

Profile

The Clinical Research Unit (CRU) supports the translation of innovative biomedical preclinical research questions into clinical application in humans.

The CRU is part of the Experimental & Clinical Research Center (ECRC), a cooperation of MDC and Charité that promotes the collaboration between basic scientists and clinical researchers. The CRU focuses on the development of new approaches for diagnosis, prevention and therapy of cardiovascular and metabolic diseases, cancer and neurological diseases.

The CRU team supports scientists and clinicians in testing their preclinical scientific hypotheses in clinical studies with healthy volunteers and/or patients.

We offer a wide range of services in conducting clinical studies, such as study design conception, administration, recruitment, study visits, data analysis, interpretation and publication, either in a supporting or leading role. We have comprehensive expertise in the field of metabolic and cardiovascular research and are always open to further interdisciplinary and methodological approaches.

 

Interviews with Anja Mähler

Team

Group Leader

Dr. Anja Mähler
Clinical Research Unit (CRU)
Experimental and Clinical Research Center (ECRC)
Phone: +49 30 450 540 323
anja.maehler@charite.de | ORCID

 

Clinicians

Michael Boschmann
michael.boschmann@charite.de | ORCID

Nadja Siebert
nadja.siebert@charite.de |
ORCID

 

Scientists

Sylvia Bähring
sylvia.baehring@charite.de | ORCID (TBA)

Kristin Kräker
kristin.kraeker@charite.de | ORCID

Till Schütte
till.schuette@charite.de |
ORCID

 

Study nurses

Gabriele Rahn
gabriele.rahn@charite.de

Elena Steinle
elena.steinle@charite.de

Heike Schenck
heike.schenck@charite.de

Elisabeth Wernick
elisabeth.wernick@charite.de

 

Alumni

L. S. Bahr

S. Klamer

A. R. Rivera | ORCID

Administration

Core modules of the CRU

  • Comprehensive consulting
  • Study design conception
  • Administrative preparation (ethics vote, registration, etc.)
  • Recruitment of study participants
  • Execution of study visits
  • Configuration and maintenance of the clinical database (REDCap)
  • Standardized collection and preanalytics of various biomaterials
  • Data management, integrity assurance and data analysis
  • Scientific and medical documentation, communication and publication

Methods

The CRU applies a variety of state-of-the-art methods for metabolic, cardiovascular, visual and neurological phenotyping.

Central methods of the CRU

Metabolic phenotyping

  • Indirect calorimetry using the canopy method and metabolic chamber to quantify energy expenditure and substrate oxidation rates
  • Determination of body composition by air displacement plethysmography, bioelectrical impedance analysis and skinfold thickness
  • Microdialysis of adipose tissue and skeletal muscle to evaluate tissue perfusion, carbohydrate and lipid metabolism
  • Normobaric hypoxia chamber to study physiological effects of decreased oxygen concentration in ambient air
  • Continuous glucose monitoring over 14 days
  • Accelorometry for physical activity recording  
  • Assessment of dietary patterns and quantification of nutrient intake

 Cardiovascular phenotyping

  • Cardiopulmonary exercise testing to assess physical performance and quantify training effects (treadmill, cycle ergometer)
  • Standardized measurement of 24h and office blood pressure (brachial, central) and peripheral resistance
  • Schellong test
  • Flow-mediated dilatation of brachial artery
  • Noninvasive assessment of endothelial dysfunction
  • Measurement of advanced glycation end products (AGEs)
  • Dynamic retinal vessel analysis to assess vascular function
  • Measurement and analysis of pulse waveform to assess vascular stiffness (PulsePen).

Visual phenotyping

  • Imaging of retina, macula and optic nerve head using a fundus camera
  • Optical coherence tomography
  • Visual acuity tests
  • Measurement of intraocular pressure

Neurological phenotyping

  • Neurological status
  • Cognitive tests
  • Olfactory test
  • Hand grip measurement

 

Publications

2022

 

Jeran S, et al. Prediction of activity-related energy expenditure under free-living conditions using accelerometer-derived physical activity. Sci Rep. 2022. PMID 36195647.

Riveros-Rivera A, et al. Hypoxia Differentially Affects Healthy Men and Women During a Daytime Nap With a Dose-Response Relationship: a Randomized, Cross-Over Pilot Study. Front Physiol. 2022. PMID 35685284.

Mahler A, et al. Increased Salt Intake Decreases Diet-Induced Thermogenesis in Healthy Volunteers: A Randomized Placebo-Controlled Study. Nutrients. 2022. PMID 35057434.

2021

 

Bahr LS, Franz K, Mahler A. Assessing the (anti)-inflammatory potential of diets. Curr Opin Clin Nutr Metab Care. 2021. PMID 34155152.

Geisberger S, et al. Salt Transiently Inhibits Mitochondrial Energetics in Mononuclear Phagocytes. Circulation. 2021. PMID 33906377.

Bartolomaeus TUP, et al. Quantifying technical confounders in microbiome studies. Cardiovasc Res. 2021. PMID 32374853.

Maifeld A, et al. Fasting alters the gut microbiome reducing blood pressure and body weight in metabolic syndrome patients. Nat Commun. 2021. PMID 33785752.

Kozarzewski L, Maurer L, Mahler A, Spranger J, Weygandt M. Computational approaches to predicting treatment response to obesity using neuroimaging. Rev Endocr Metab Disord. 2021. PMID 34951003.

Koppold-Liebscher DA, et al. Effects of Daytime Dry Fasting on Hydration, Glucose Metabolism and Circadian Phase: A Prospective Exploratory Cohort Study in Baha'i Volunteers. Front Nutr. 2021. PMID 34395487.

Mahler A, et al. Metabolic Response to Daytime Dry Fasting in Baha'i Volunteers-Results of a Preliminary Study. Nutrients. 2021. PMID 35011024.

2020

 

Mahler A, Wilck N, Rauch G, Dechend R, Muller DN. Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study. Trials. 2020. PMID 33375942.

Boschmann M, et al. Effects of dietary protein-load and alkaline supplementation on acid-base balance and glucose metabolism in healthy elderly. Eur J Clin Nutr. 2020. PMID 32873957.

Ortl M, et al. Digitalizing Nursing in the Bavarian Swabia Region of Germany - Presentation of the Joint Project CARE REGIO. Stud Health Technol Inform. 2020. PMID 32604652.

Mai K, et al. Hypoxia and exercise interactions on skeletal muscle insulin sensitivity in obese subjects with metabolic syndrome: results of a randomized controlled trial. Int J Obes (Lond). 2020. PMID 31819201.

Bahr LS, et al. Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study. Trials. 2020. PMID 31898518.

2019

 

Aktas MF, et al. Lifestyle interventions in Muslim patients with metabolic syndrome-a feasibility study. Eur J Clin Nutr. 2019. PMID 30538299.

2018

 

Klug L, et al. Normobaric hypoxic conditioning in men with metabolic syndrome. Physiol Rep. 2018. PMID 30565412.

Mahler A, et al. Metabolic, Mental and Immunological Effects of Normoxic and Hypoxic Training in Multiple Sclerosis Patients: A Pilot Study. Front Immunol. 2018. PMID 30555484.

Haas V, et al. Metabolic Barriers to Weight Gain in Patients With Anorexia Nervosa: A Young Adult Case Report. Front Psychiatry. 2018. PMID 29867616.

2017

 

Wilck N, et al. Salt-responsive gut commensal modulates TH17 axis and disease. Nature. 2017. PMID 29143823.

Haufe S, et al. Branched-chain amino acid catabolism rather than amino acids plasma concentrations is associated with diet-induced changes in insulin resistance in overweight to obese individuals. Nutr Metab Cardiovasc Dis. 2017. PMID 28958691.

Klaer J, et al. Longer-term impact of hemiparetic stroke on skeletal muscle metabolism-A pilot study. Int J Cardiol. 2017. PMID 28063669.

Adler C, et al. Validity and reliability of total body volume and relative body fat mass from a 3-dimensional photonic body surface scanner. PLoS One. 2017. PMID 28672039.

2015 - 2010

 

Mossakowski AA, et al. Tracking CNS and systemic sources of oxidative stress during the course of chronic neuroinflammation. Acta Neuropathol. 2015. PMID 26521072.

Haufe S, et al. Differential response of the natriuretic peptide system to weight loss and exercise in overweight or obese patients. J Hypertens. 2015. PMID 25882864.

Mahler A, et al. Metabolic response to epigallocatechin-3-gallate in relapsing-remitting multiple sclerosis: a randomized clinical trial. Am J Clin Nutr. 2015. PMID 25733633.

Mahler A, Steiniger J, Endres M, Paul F, Boschmann M, Doss S. Increased catabolic state in spinocerebellar ataxia type 1 patients. Cerebellum. 2014. PMID 24604678.

Haufe S, et al. Long-lasting improvements in liver fat and metabolism despite body weight regain after dietary weight loss. Diabetes Care. 2013. PMID 23963894.

Szabo T, et al. Increased catabolic activity in adipose tissue of patients with chronic heart failure. Eur J Heart Fail. 2013. PMID 23696611.

Pakula A, et al. Altered expression of cyclin A 1 in muscle of patients with facioscapulohumeral muscle dystrophy (FSHD-1). PLoS One. 2013. PMID 24019929.

Mahler A, et al. Epigallocatechin-3-gallate: a useful, effective and safe clinical approach for targeted prevention and individualised treatment of neurological diseases? EPMA J. 2013. PMID 23418936.

Mahler A, et al. Is metabolic flexibility altered in multiple sclerosis patients? PLoS One. 2012. PMID 22952735.

Haufe S, et al. Left ventricular mass and function with reduced-fat or reduced-carbohydrate hypocaloric diets in overweight and obese subjects. Hypertension. 2012. PMID 22068866.

Haufe S, et al. Randomized comparison of reduced fat and reduced carbohydrate hypocaloric diets on intrahepatic fat in overweight and obese human subjects. Hepatology. 2011. PMID 21400557.

Boschmann M, et al. LMNA mutations, skeletal muscle lipid metabolism, and insulin resistance. J Clin Endocrinol Metab. 2010. PMID 20130076.

 

Studies

Here you can find recruiting and recent studies conducted at the CRU.

Recruiting studies

CARPE

Endothelial function and cardiovascular risk after preeclamptic pregnancy.

Aim of the study

Epidemiological studies have shown that preeclamptic pregnancy increases cardiovascular risk up to fourfold. In this study, we want to investigate vascular function at different body parts (myocardium, upper arm, fingertips, and fundus of the eye) and identify potential biomarkers for early detection of increased long-term risk. For this, we are recruiting subjects after a preeclamptic pregnancy and healthy controls.

NCT-Nummer: NCT05277233

Duration: 2021-ongoing

We are looking for Probands!

CORAL

Retinal vascular function in vasospastic angina.

Aim of the study

Vasospastic angina, also called Prinzmetal's angina or "syndrome X," is caused by epicardial coronary artery spasm and results in atypical chest pain whether or not the patient is under physical stress. The exact mechanism leading to vasospastic angina is not yet fully elucidated. Non-invasive dynamic imaging of the retinal vessels using the "retinal flicker test", which allows measurement of microvascular function, is considered a promising approach. The aim of this study is to correlate coronary and retinal vascular function.

NCT number: TBA

Duration: 2022-ongoing

ED-S

Immunological and cardiovascular phenotyping of oocyte-donation pregnancies.

Aim of the study

Pregnancies resulting from oocyte-donation have a strikingly increased risk of developing preeclampsia. The aim of this study is to investigate the interplay between various immune and placental cells and their potential to cause pregnancy-related diseases after conception from oocyte-donation. We will investigate if immune cell subtypes are causally involved in the development of preeclampsia by triggering endothelial imbalance and leading to increased cardiovascular risk later in life.

NCT number: NCT04731012

Duration: 2021-ongoing

We are looking for Probands!

HYPRO

Effects of a probiotic on hypertension.

Aim of the study

High blood pressure is a major risk factor for cardiovascular events such as stroke, heart and kidney failure. Typical antihypertensive drugs exert their effects on vessels, the kidneys or the heart. In this randomized, placebo-controlled trial, we test the antihypertensive effect of a probiotic in patients with grade 1 hypertension (130-159 and/or 80-99 mmHg). In addition, we will assess glucose variability, gut microbiome composition, bacterial metabolites in stool and blood, frequency of peripheral immune cells, and health-related quality of life.

NCT number: NCT03906578

Duration: 2019-ongoing

We are looking for Patients!

LONGKID

Alterations in living kidney donations with respect to renal function, immune system and gut microbiome.

Aim of the study

The aim of the study is to investigate causal relationships between alterations in kidney function and alterations in the immune system and gut microbiome. For this purpose, couples of donor and recipient of living kidney donations residing in the same household will be observed.

NCT number: NCT05570929

Duration: 2022-ongoing

We are looking for Patients!

PRECOMS

Pregnancy cohort in multiple sclerosis.

Aim of the study

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system primarily affecting women. It usually first appears between the ages of 20 and 40, a period of life associated with family planning and the desire to have children. In the past, pregnancy in MS patients was thought to be a risk, and in some cases, even abortion was recommended. This still causes doubt and uncertainty in MS patients and their partners. This study aims to assess the impact of pregnancy on MS by studying its course (number of relapses, disability progression, relapse symptoms, administered therapies, response to therapy) before, during and after pregnancy.

NCT number: NCT05010902

Duration: 2021-ongoing

We are looking for Patients!

RESTORE

Effect of inulin on gut microbiota and gut barrier in chronic kidney disease.

Aim of the study

Patients with chronic kidney disease (CKD) exhibit an altered composition of the gut microbiota (dysbiosis) compared to healthy individuals, which is accompanied by a disturbed gut barrier. This dysbiosis is, among others, a consequence of a low-fiber diet. In this randomized, placebo-controlled study, we will investigate the effects of the prebiotic inulin on CKD course, gut microbiome composition, gut epithelial barrier, bacterial metabolites, immune cells and acid-base status.

NCT number: NCT05071131

Duration: 2021-ongoing

We are looking for Patients!

Recent studies - not recruiting

FSHD

Interaction of Muscle Dystrophy, Glucose Metabolism and Insulin Sensitivity.

Aim of the study

During moderate and high physical activity, the skeletal muscle requires glucose oxidation in addition to fatty acids to meet its energy requirements. This glucose is primarily derived from intramuscular glycogen stores. Consequently, impaired energy supply from glucose leads to reduced muscular performance. Genetic muscular dystrophies are commonly associated with impaired glucose tolerance. However, the metabolic phenotype of facioscapulohumeral muscular dystrophy (FSHD) is still unclear. In this study, we investigate changes of energy metabolism in FSHD patients compared to healthy controls. We hypothesize that mitochondrial dysfunction leads to impaired glucose tolerance and insulin sensitivity, which in turn contribute to exercise intolerance.

NCT number: NCT05052073

Duration: 2009-ongoing, not recruiting

LEANER

Physiological response to 5 days fasting.

Aim of the study

This study examines the effects of a 5-day Buchinger fast on energy metabolism, body composition, office blood pressure, gut microbiome, various metabolic and immune parameters, glucose variability, and neuronal mechanisms of emotion processing and food-specific delayed gratification in healthy adults. Medium-term effects will be verified 3 months after the fast.

NCT number: NCT04452916

Duration: 2020-ongoing, not recruiting

NAMS

Nutritional Approaches in Multiple Sclerosis.

Aim of the study

This study investigates the efficacy of three nutritional approaches on disease progression in patients with multiple sclerosis (MS). These approaches are 1) 7-day fasts every 6 months and 14h intermittent fasting in between, 2) a diet high in fat and low in carbohydrates (ketogenic diet), and 3) an anti-inflammatory, primarily plant-based diet according to the recommendations of the German Nutrition Society (DGE). We hypothesize that the efficacy of the diets differs with respect to new brain MRI lesions, MS disability progression, relapse rate, quality of life, gut microbiome composition, and various metabolic markers.

NCT number: NCT03508414

Study protocol

Duration: 2017-2021

Probands/Patients

CARPE

Clinical study addressing preeclamptic pregnancy and vascular function.

Epidemiological studies have shown that preeclamptic pregnancy increases cardiovascular risk up to fourfold. In this study, we aim to investigate vascular function at different body parts (myocardium, upper arm, fingertips and fundus of the eye) and to identify potential biomarkers for early detection of increased long-term risk.

To do this, we are looking for subjects after a preeclamptic pregnancy and healthy controls, whose first pregnancy was 5 to 10 years ago.

The study is conducted in the Clinical Research Unit of the Experimental & Clinical Research Center at the Charité Campus Berlin-Buch, as well as at the Helios Klinikum Berlin-Buch in two visits. The total time required is approximately 6 hours. An appropriate financial allowance is guaranteed.

You will also receive:

  • A magnetic resonance tomography (MRT) of the heart
  • Individual information about body composition, blood pressure and vascular stiffness
  • Assessment of visual acuity, as well as an analysis of retinal vasculature

You can find more information at the study register of Charité.

Have we met your interest? Then please contact us at:

(030) 450 540 565 or carpe@charite.de.

CORAL

Study to develop a diagnostic method of vasospastic angina.

The aim of this study is to develop a non-invasive diagnostic method for vasospastic angina. We will deploy a state-of-the-art method for dynamic vascular imaging of the retinal microvasculature ("retinal flicker test"). In addition, further insights into the pathomechanism underlying coronary vasospasm will be investigated by molecular biological analyses.

You will receive a comprehensive eye examination (approx. 45 min):

  • Intraocular pressure measurement
  • Visual acuity test using autorefractometer
  • High-resolution retinal image and periphery by ultra-widefield funduscopy
  • 2-Dimensional imaging of the ocular fundus via optical coherence tomography (OCT)
  • Determination of endothelial function by means of dynamic vascular analysis (DVA).

Subsequently, you are unable to drive for about 4 hours, as a measurement-related pupil dilatation (mydriasis) is performed.

The study visit will be conducted in the Clinical Research Unit of the Experimental & Clinical Research Center at the Charité Campus Berlin-Buch.

More information can be found in the Charité study register (TBA).

ED-S

A scientific study on pregnancy.

Are you...

  • over 18 years old and became pregnant
  • by natural means or
  • through IVF and/or ICSI treatment or
  • through egg donation?

... then, we invite you to participate in our scientific study.

What do you have expect during the study?

We will examine you up to three times during your pregnancy and perform a general health check including a blood sample drawing. If we discover any abnormal findings, we will offer treatment in our specialized outpatient clinics.

You will receive a reasonable expense allowance for your participation. You might refuse examinations at any time. All data will be handled in a strictly confidential way.

What is the purpose of the study?

It is already known that pregnant women have an increased risk of hypertension during and after pregnancy due to egg donation. We aims to develop improved therapies that can address the specific needs of these women.

You can find more information at the study register of Charité.

Are you interested? Then please contact us by phone or email:

(030) 450 540 565 or  ecrc-schwangerschaftsstudie@charite.de.

Subject: Egg donation

HYPRO

Subjects with high blood pressure wanted for study!

Is your blood pressure either treated or untreated above 130/80? Are you between 50 and 80 years? Are you looking for an alternative treatment that can lower your blood pressure?

Then our HYPRO study would be just right for you! We are investigating the influence of a probiotic (preparation of viable bacteria) on blood pressure, the intestinal microbiome and glucose metabolism.

You can find more information at the study register of Charité.

If you are interested, please contact us at:

(030) 450 540 565 / 234 or hypro@charite.de.

LONGKID

A longitudinal study investing kidney function, immune system and microbiome alterations during kidney transplantation.

Acute and chronic kidney disease are frequently and rising worldwide. In the final stage of kidney disease only hemodialysis or a kidney transplant are available as treatment options. We would like to investigate the influence of loss and gain of a healthy kidney after transplantation in donor couples.

The study will be conducted at the Experimental & Clinical Research Center (ECRC) in Berlin-Buch.

 We are looking for

  • Men and women
  • Between 18 to 75 years old
  • Pending living kidney donation
  • Donor and recipient of the kidney living in the same household

Your benefits:

  • A thorough health check
  • Individualized information about body composition and blood pressure
  • A detailed dietary analysis
  • An appropriate financial allowance

You can find more information at the study register of Charité (TBA).

If you are interested, please contact us at:

(030) 450 540 234 or longkid@charite.de.

PRECOMS

Fertility and pregnancy in multiple sclerosis.

Pregnancy brings about many chances in a woman’s body and affects the course of multiple sclerosis (MS). In this cohort study, we accompany MS patients before, during and after a pregnancy, in order to study the pregnancies’ influence on MS and counsel patients individually.

Every three months we will:

  • Evaluate general and neurological status
  • Ask for depression, sleep quality, fatigue and quality of life
  • Take blood samples
  • Non-invasively investigate the retina by optical coherence tomography (OCT)
  • Perform a brain MRI (only before and after pregnancy)

Allowance: 25 Euro/visit (max. 9 visits)

You can find more information at the study register of Charité.

If you are interested, please contact:

Charité - University Medicine Berlin

Clinical Research Unit (CRU)

Experimental and Clinical Research Center (ECRC)

(030) 450 540 565 or precoms@charite.de.

RESTORE

A nutritional study for patients with chronic kidney disease.

Patients with chronic renal failure often have an unfavorable composition of bacteria in the gut (dysbiosis), which can increase the permeability of the intestinal wall and stimulate inflammatory processes. We would like to investigate whether the prebiotic inulin can positively influence this dysbiosis and the permeability of the intestinal wall.

For this, we are recruiting men and women with renal failure requiring dialysis who are between 18 and 70 years.

The study will be conducted at the Experimental & Clinical Research Center (ECRC) in Berlin-Buch.

Your benefits:

  • A thorough health check
  • Individualized information about body composition, blood pressure and vascular stiffness
  • A detailed dietary analysis and individualized nutritional counselling
  • An appropriate financial allowance

You can find more information at the study register of Charité.

If you are interested, please contact us at:

(030) 450 540 464 or restore@charite.de.