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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2011 by German Diabetes Center.
Recruitment status was: Not yet recruiting

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:

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


Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Allergy Weight Loss Surgery

Drug Information available for: Insulin Insulin human

U.S. FDA Resources

Further study details as provided by German Diabetes Center:

Primary Outcome Measures:

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:

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


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 (Adult, Senior)
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

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


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

Keywords provided by 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

ClinicalTrials.gov processed this record on May 25, 2017

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