ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborators:
Dep.of General-, Visceral- and Pediatric Surgery, HHU, Duesseldorf
Dep.for Metabolic Diseases, HHU, Duesseldorf
Information provided by (Responsible Party):
julia szendrödi, German Diabetes Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The purpose of this study is:

  1. To explore to what extent insulin sensitivity, energy metabolism and ectopic lipid storage can be improved by bariatric surgery
  2. To explore to what extent hepatic and muscular disorders of energy metabolism occur in patients with obesity (degree 2-3)
  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

Detailed Description:

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Surgery
bariatric surgery
 Procedure: surgery
biliopancreatic diversion, gastric banding, gastric sleeve resection
Other Name: bariatric surgery


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. weight loss [ Time Frame: four year ]
    body weight and body composition before and after bariatric surgery

  2. Insulin sensitivity [ Time Frame: four years ]
    Whole body glucose uptake and enfogenous glucose production as measure of skeletal muscle and hepatic insulin sensitivity


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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   
Sponsors and Collaborators
German Diabetes Center
Dep.of General-, Visceral- and Pediatric Surgery, HHU, Duesseldorf
Dep.for Metabolic Diseases, HHU, Duesseldorf
Investigators
Principal Investigator: Julia Szendrödi, MD, PhD German Diabetes Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Homepage  This link exits the ClinicalTrials.gov site

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