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OpenTrials
Completed

NCT Number: NCT01167959

Hypothalamic Function Before and After Bariatric Surgery

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.

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Key information

Age range

35 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Leiden University Medical Centre

Leiden, South Holland, 2333 ZA, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roux en Y gastric bypass and lap. gastric banding

Procedure

Standard RYGB and LAGB procedures

Prodimed dietary intervention

Behavioral

3 months of using the prodimed diet

Primary outcomes

  1. Changes in gut hormones

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jul 22, 2010
Registry last updated
Dec 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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