Hypothalamic Function Before and After Bariatric Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167959
• Other study ID #: P08-215
• Status: Completed
• Phase: N/A
• First received: July 21, 2010
• Last updated: December 20, 2012
• Start date: June 2009
• Est. completion date: May 2012

Study information

• Verified date: December 2012
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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 type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Procedure:
• Roux en Y gastric bypass and lap. gastric banding
Standard RYGB and LAGB procedures

Behavioral:
• Prodimed dietary intervention
3 months of using the prodimed diet

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Centre	Leiden	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gut hormones		3 weeks	No