The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism (Bariatrix)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01477957 |
Recruitment Status
:
Recruiting
First Posted
: November 23, 2011
Last Update Posted
: September 14, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
The purpose of this study is:
- To explore to what extent insulin sensitivity, energy metabolism and ectopic lipid storage can be improved by bariatric surgery
- To explore to what extent hepatic and muscular disorders of energy metabolism occur in patients with obesity (degree 2-3)
- To explore whether the steato liver occurring in patients with obesity (degree 2-3) is associated with the degree of liver inflammation
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Diabetes Mellitus, Non-Insulin-Dependent | Procedure: surgery | Not Applicable |
Insulin resistance strongly relates to ectopic lipid deposition in skeletal muscle and the liver, which correlate with insulin resistance. Lipid metabolites accumulating in skeletal muscle and the liver are thought to impair insulin signalling and thereby reduce glucose uptake and glycogen storage. Insulin resistant humans frequently present with decreased mitochondrial function in skeletal muscle which might contribute to lipid accumulation and the development of insulin resistance. Non-alcoholic liver disease (NAFLD) comprise fatty liver, steatohepatitis and cirrhosis. NAFLD correlate with insulin resistance increased risk for cardiovascular diseases, type 2 diabetes and hepatocellular. The mechanisms leading from fatty liver to steatohepatitis and insulin resistance in the liver are yet unclear. Bariatric surgery relates to surgery for the reduction of body weight. Bariatric surgery frequently leads to normalization of glucose tolerance in previously diabetic humans even before the onset of body weight reduction. The underlying mechanisms are yet unclear. In this study we aim to explore the mechanisms underlying the onset of insulin resistance and steatohepatitis in patients with fatty liver and to identify the mechanisms leading to improved glucose tolerance in humans after bariatric surgery. We test the following hypotheses: increased lipid availability leads to (i) increased lipid oxidation and oxidative stress (ii) accumulation of lipid metabolites that impair insulin signalling (iii) bariatric surgery improves insulin sensitivity by increasing lipid oxidation.
This study will contribute to the understanding of NAFLD and will help to identify new targets for the therapy of diabetes.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Assessment of the Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism |
Study Start Date : | September 2012 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Surgery
bariatric surgery
|
Procedure: surgery
biliopancreatic diversion, gastric banding, gastric sleeve resection
Other Name: bariatric surgery
|
- Energy metabolism [ Time Frame: 4 years ]whole body substrate oxidation, ex vivo mitochondrial function via measurement of high resolution respirometry and in vivo mitochondrial function via measurement of ATP production
- weight loss [ Time Frame: four year ]body weight and body composition before and after bariatric surgery
- Insulin sensitivity [ Time Frame: four years ]Whole body glucose uptake and enfogenous glucose production as measure of skeletal muscle and hepatic insulin sensitivity

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Aged ≥ 30 years- ≤ 70 years
- Balanced sex (50: 50)
- BMI 20- 25 kg/m 2 normal- weight group
- BMI 35- 39,9 kg/m 2 (Obese type II)
- BMI >40 kg/m 2 (Obese type III)
Exclusion Criteria:
- Acute illness 2 weeks before start of examination
- Autoimmune or Immune disorder diseases (Leukozyten < 5000/µl
- Renal insufficiency (Kreatin > 1,5 mg/dl)
- Heart disease, condition after heart attack
- Anemia (Hb <12g/l, controlled before every day of examination) or blood donations 4weeks before examination.
- Participation in another trial within the last 2 weeks
- Pharmacological- immunotherapy (Cortisol, Antihistaminika, ASS)
- Thyroid disorders
- Glitazone or Insulin- Therapy
- Pregnancy, Lactation, Menstruation
- Smoking cigarettes, Alcohol- and drug abuse
- Psychiatric disorders
- Risk for/ or diagnosed HIV/ AIDS or Hepatitis B/C
- Liver disease, which are not caused by non- alcoholic steato- hepatitis
- Working on night shifts or irregular rhythm of night- day
- Impaired wound healing or clotting disorders
- Allergic reaction to local anesthetics
- Malignant cancer

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477957
Germany | |
DDZ (Deutsches Diabetes Zentrum) | Recruiting |
Düsseldorf, NRW, Germany, 40225 | |
Contact: Michael Roden, Prof. med. 49(0) 2 11-33 82-201 roden@ddz.uni-duesseldorf.de | |
Contact: Julia Szendrödi, Dr. med Ph.D 0211/3382-203 julia.Szendroedi@ddz.uni-duesseldorf.de |
Principal Investigator: | Julia Szendrödi, MD, PhD | German Diabetes Center |
Additional Information:
Publications of Results:
Responsible Party: | julia szendrödi, Dr PhD, German Diabetes Center |
ClinicalTrials.gov Identifier: | NCT01477957 History of Changes |
Other Study ID Numbers: |
Bariatrix |
First Posted: | November 23, 2011 Key Record Dates |
Last Update Posted: | September 14, 2017 |
Last Verified: | September 2017 |
Keywords provided by julia szendrödi, German Diabetes Center:
weight loss after bariatric surgery Insulin sensitivity insulin resistance |
Additional relevant MeSH terms:
Diabetes Mellitus Hypersensitivity Insulin Resistance Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Immune System Diseases Hyperinsulinism Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs |