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NCT01477957Recruiting

The Effect 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

Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
450 (estimated)
First submitted
13 Nov 2011
Start date
Sept 2012
Primary completion date
Dec 2028
Lead sponsor
German Diabetes Center
NCT number
NCT01477957

What you commit to

  • Study type: Observational
  • Planned participants: 450
  • From Sept 2012 to the primary completion date, Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Acute illness 2 weeks before start of examination
  • Pharmacological- immunotherapy (Cortisol, Antihistaminika, ASS)
  • Glitazone Therapy
  • Smoking cigarettes, Alcohol- and drug abuse

Other illness

  • Autoimmune or Immune disorder diseases (Leukozyten \< 5000/µl
  • Heart disease, condition after heart attack
  • Thyroid disorders
  • Psychiatric disorders
  • Risk for/ or diagnosed HIV/ AIDS or Hepatitis B/C
  • Liver disease, which are not caused by non- alcoholic steato- hepatitis
  • Impaired wound healing or clotting disorders
  • Allergic reaction to local anesthetics
  • Malignant cancer

Lab values

  • Renal insufficiency (Kreatin \> 1,5 mg/dl)

Other

  • 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
  • Pregnancy, Lactation, Menstruation
  • Working on night shifts or irregular rhythm of night- day

Who the study is looking for

  • 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)

Age in the registry: 20 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
German Diabetes Center
Coordinator of this site? Confirm its status
DüsseldorfGermanyRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.