Impact of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism
The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism in Obesity Grade 2 -3
This study looks at how bariatric surgery can improve insulin sensitivity and energy use in people with obesity to see how it helps their overall metabolic health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | German Diabetes Center Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Trial ID | NCT01477957 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how bariatric surgery affects insulin sensitivity, energy metabolism, and ectopic lipid storage in patients with obesity. It aims to understand the relationship between hepatic and muscular energy metabolism disorders and the degree of liver inflammation in obese individuals. The study will explore the mechanisms that lead to improved glucose tolerance following bariatric surgery, focusing on lipid metabolism and insulin signaling. Participants will be monitored for changes in their metabolic health post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 to 70 with obesity (BMI ≥ 35) or normal weight (BMI 20-25).
Not a fit: Patients with acute illnesses, autoimmune disorders, or significant comorbidities such as heart disease or liver disease unrelated to non-alcoholic steatohepatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for obesity and type 2 diabetes by enhancing our understanding of metabolic changes after bariatric surgery.
How similar studies have performed: Other studies have shown promising results regarding metabolic improvements following bariatric surgery, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Düsseldorf, North Rhine-Westphalia
- German Diabetes Center — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Michael Roden, Prof., MD — German Diabetes Center
- Study coordinator: Sabine Kahl, MD
- Email: sabine.kahl@ddz.de
- Phone: 0049211-3382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.