Status:
RECRUITING
The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism
Lead Sponsor:
German Diabetes Center
Collaborating Sponsors:
Dep.of General-, Visceral- and Pediatric Surgery, HHU, Duesseldorf, Germany
Dep.for Metabolic Diseases, HHU, Duesseldorf, Germany
Conditions:
Obesity
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-70 years
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 a...
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 liv...
Eligibility Criteria
Inclusion
- Aged ≥ 20 years- ≤ 70 years
- BMI 20- 25 kg/m 2 normal- weight group
- BMI 35- 39,9 kg/m 2 (Obesity grade 2)
- BMI \>40 kg/m 2 (Obesity grade 3)
Exclusion
- 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 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
Key Trial Info
Start Date :
September 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT01477957
Start Date
September 1 2012
End Date
December 1 2028
Last Update
January 10 2025
Active Locations (1)
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1
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, Germany, 40225