Status:
COMPLETED
Hypothalamic Function Before and After Bariatric Surgery
Lead Sponsor:
Leiden University Medical Center
Conditions:
Obesity
Diabetes
Eligibility:
FEMALE
35-65 years
Brief Summary
The purpose of this study is to determine the effect of gastric banding or gastric bypass on hypothalamic morphology and function, gut hormones and systems biology in obese subjects with and without t...
Eligibility Criteria
Inclusion
- Patients aged 35-65 years;
- BMI \> 40 kg/m2;
- BMI \> 35 and \<40 kg/m2 with co-morbidity, which is expected to improve after surgically-induced weight loss;
- A history of longstanding obesity (\>5 years);
- Proven failed attempts to lose weight in a conventional way, or primarily successful weight loss with eventual weight regain;
- Intention to adhere to a postoperative follow-up programme.
Exclusion
- BMI\> 50 or body weight \> 150 kg (because it is impossible to safely put people above this weight on a standard table for MRI);
- Subjects with disease related obesity, i.e. Cushing or medication related obesity;
- Use of medication known to affect glucose or lipid metabolism (i.e. prednisone)
- Monogenetic diabetes: MODY, Mitochondrial diabetes;
- LADA (adult-onset latent autoimmune diabetes); detected by c-peptide measurement on screening.
- Impaired renal function (serum creatinine \> 176 μmol/L);
- Leg ulcers, gangrene.
- Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression) affecting the brain
- Any significant chronic disease
- Renal or hepatic disease
- Pregnancy
- Recent weight changes or attempts to loose weight (\> 3 kg weight gain or loss, within the last 3 months)
- Aerobic exercise more that 3 times 60 minutes a week
- Alcohol consumption of more than 28 units per week at present or in the past
- Recent blood donation (within the last 2 months)
- Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
- Contra-indications to operative procedures as regular in bariatric surgery
- Contra-indications to MRI scanning
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01167959
Start Date
June 1 2009
End Date
May 1 2012
Last Update
December 24 2012
Active Locations (1)
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1
Leiden University Medical Centre
Leiden, South Holland, Netherlands, 2333 ZA