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Hypothalamic Function Before and After Bariatric Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167959
First Posted: July 22, 2010
Last Update Posted: December 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mirjam Anne Lips, Leiden University Medical Center
  Purpose
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.

Condition Intervention
Obesity Diabetes Procedure: Roux en Y gastric bypass and lap. gastric banding Behavioral: Prodimed dietary intervention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Mirjam Anne Lips, Leiden University Medical Center:

Primary Outcome Measures:
  • Changes in gut hormones [ Time Frame: 3 weeks ]

Biospecimen Retention:   Samples Without DNA
Blood/Sera Adipose tissue biopsies

Enrollment: 48
Study Start Date: June 2009
Study Completion Date: May 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
obesity diabetes, surgical and dietary 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Obese (type 2 diabetic or not) population from primary care (dietary intervention) and hospital setting (bariatric surgery)
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167959


Locations
Netherlands
Leiden University Medical Centre
Leiden, Zuid Holland, Netherlands, 2333 ZA
Sponsors and Collaborators
Leiden University Medical Center
Investigators
Principal Investigator: Hanno Pijl, MD Phd Proff Leiden University Medical Centre
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mirjam Anne Lips, drs, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01167959     History of Changes
Other Study ID Numbers: P08-215
First Submitted: July 21, 2010
First Posted: July 22, 2010
Last Update Posted: December 24, 2012
Last Verified: December 2012

Keywords provided by Mirjam Anne Lips, Leiden University Medical Center:
Obesity
Diabetes
Bariatric surgery