Hypothalamic Function Before and After Bariatric Surgery

NCT01167959 | Completed DMC

• 1 other identifier: P08-215
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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 type 2 diabetes.

Conditions

Obesity; Diabetes

Keywords

Obesity; Diabetes; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Changes in gut hormones

  3 weeks

Study Arms (1)

obesity diabetes, surgical and dietary

Procedure: Roux en Y gastric bypass and lap. gastric banding; Behavioral: Prodimed dietary intervention

Interventions

Roux en Y gastric bypass and lap. gastric banding PROCEDURE

Standard RYGB and LAGB procedures

obesity diabetes, surgical and dietary

Prodimed dietary intervention BEHAVIORAL

3 months of using the prodimed diet

obesity diabetes, surgical and dietary

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Obese (type 2 diabetic or not) population from primary care (dietary intervention) and hospital setting (bariatric surgery)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Centre

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (4)

• Maessen DE, Hanssen NM, Lips MA, Scheijen JL, Willems van Dijk K, Pijl H, Stehouwer CD, Schalkwijk CG. Energy restriction and Roux-en-Y gastric bypass reduce postprandial alpha-dicarbonyl stress in obese women with type 2 diabetes. Diabetologia. 2016 Sep;59(9):2013-7. doi: 10.1007/s00125-016-4009-1. Epub 2016 Jun 16.

  PMID: 27312699 DERIVED

• Lips MA, Van Klinken JB, van Harmelen V, Dharuri HK, 't Hoen PA, Laros JF, van Ommen GJ, Janssen IM, Van Ramshorst B, Van Wagensveld BA, Swank DJ, Van Dielen F, Dane A, Harms A, Vreeken R, Hankemeier T, Smit JW, Pijl H, Willems van Dijk K. Roux-en-Y gastric bypass surgery, but not calorie restriction, reduces plasma branched-chain amino acids in obese women independent of weight loss or the presence of type 2 diabetes. Diabetes Care. 2014 Dec;37(12):3150-6. doi: 10.2337/dc14-0195. Epub 2014 Oct 14.

  PMID: 25315204 DERIVED

• Lips MA, Wijngaarden MA, van der Grond J, van Buchem MA, de Groot GH, Rombouts SA, Pijl H, Veer IM. Resting-state functional connectivity of brain regions involved in cognitive control, motivation, and reward is enhanced in obese females. Am J Clin Nutr. 2014 Aug;100(2):524-31. doi: 10.3945/ajcn.113.080671. Epub 2014 Jun 25.

  PMID: 24965310 DERIVED

• Lips MA, Pijl H, van Klinken JB, de Groot GH, Janssen IM, Van Ramshorst B, Van Wagensveld BA, Swank DJ, Van Dielen F, Smit JW. Roux-en-Y gastric bypass and calorie restriction induce comparable time-dependent effects on thyroid hormone function tests in obese female subjects. Eur J Endocrinol. 2013 Aug 28;169(3):339-47. doi: 10.1530/EJE-13-0339. Print 2013 Sep.

  PMID: 23811187 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood/Sera Adipose tissue biopsies

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Hanno Pijl, MD Phd Proff

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: drs

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: June 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2012
• Last Updated: December 24, 2012

Record last verified: 2012-12

Locations

NL (1)