Hypothalamic Function Before and After Bariatric Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mirjam Anne Lips, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01167959
First received: July 21, 2010
Last updated: December 20, 2012
Last verified: December 2012
  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 Leiden University Medical Center:

Primary Outcome Measures:
  • Changes in gut hormones [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   35 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Leiden University Medical Center

Additional 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
Study First Received: July 21, 2010
Last Updated: December 20, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:
Obesity
Diabetes
Bariatric surgery

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014