The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism
Recruiting · NCT01477957 · Observational (researchers observe without assigning treatment) · Lead sponsor: German Diabetes Center
View the official record on ClinicalTrials.gov →Interventions studied
surgery
What this trial is about
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
Who can take part
Age range
20 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 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 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
Where it is running
1 location listed.
- German Diabetes Center - Düsseldorf, North Rhine-Westphalia, Germany