Hypothalamic Function Before and After Bariatric Surgery

Study Overview
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Brief Summary
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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 type 2 diabetes.

Official Title
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Hypothalamic Morphology, Neuronal Activity and Systems Biology in Response to Food Intake in Obese Patients With Type 2 Diabetes Mellitus Compared to Obese and Lean Controls

Conditions
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Obesity, Diabetes

Intervention / Treatment
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* Procedure: Roux en Y gastric bypass and lap. gastric banding
* Behavioral: Prodimed dietary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| obesity diabetes, surgical and dietary<br> | Procedure: Roux en Y gastric bypass and lap. gastric banding<br>* Standard RYGB and LAGB procedures<br>Behavioral: Prodimed dietary intervention<br>* 3 months of using the prodimed diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gut hormones |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Diabetes, Bariatric surgery