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The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism (Bariatrix)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2011 by German Diabetes Center
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
ClinicalTrials.gov Identifier:
NCT01477957
First received: November 13, 2011
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Obesity
Diabetes Mellitus, Non-Insulin-Dependent
 Procedure: surgery

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Assessment of the Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism

Resource links provided by NLM:

Drug Information available for: Insulin
U.S. FDA Resources

Further study details as provided by German Diabetes Center:

Primary Outcome Measures:
  • Energy metabolism [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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:
  • weight loss [ Time Frame: four year ] [ Designated as safety issue: No ]
    body weight and body composition before and after bariatric surgery

  • Insulin sensitivity [ Time Frame: four years ] [ Designated as safety issue: No ]
    Whole body glucose uptake and enfogenous glucose production as measure of skeletal muscle and hepatic insulin sensitivity
Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgery
bariatric surgery
 Procedure: surgery
biliopancreatic diversion, gastric banding, gastric sleeve resection
Other Name: bariatric surgery

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.

  Eligibility
Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477957

Locations
Germany
DDZ (Deutsches Diabetes Zentrum) Not yet 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

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

No publications provided

Responsible Party: julia szendrödi, Dr PhD, German Diabetes Center
ClinicalTrials.gov Identifier: NCT01477957     History of Changes
Other Study ID Numbers: Bariatrix
Study First Received: November 13, 2011
Last Updated: November 22, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by German Diabetes Center:
weight loss after bariatric surgery
Insulin sensitivity
insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on March 03, 2015