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Bariatric Surgery and HDL-cholesterol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707771
First Posted: October 16, 2012
Last Update Posted: October 16, 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):
Geltrude Mingrone, Catholic University of the Sacred Heart
  Purpose

Objective: to assess the effect of gastric bypass on HDL-cholesterol concentration and its Apolipoprotein A4 content at 1 year following bariatric surgery in comparison with a hypocaloric diet. Secondary aim was to measure total cholesterol and triglycerides levels as well as insulin sensitivity after interventions.

Summary Background Data: Very few prospective uncontrolled studies have investigated the effects of Roux-en-Y gastric bypass (RYGB) on cardiovascular risk factors. No controlled studies had as primary goal the changes in HDL-cholesterol after gastric bypass.

Methods: Forty subjects with a BMI>40 or ≥35 kg/m2 in the presence of diabetes were enrolled.

Twenty of them were operated of RYGB while 20 received lifestyle modification suggestions and medical therapy for obesity complications (diabetes, hypertension and hyperlipidemia).


Condition Intervention
Morbid Obesity Procedure: Roux-en-Y gastric bypass Behavioral: diet and lifestyle modifications

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Gastric Bypass Versus Diet on Cardiovascular Risk Factors

Resource links provided by NLM:


Further study details as provided by Geltrude Mingrone, Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • changes in HDL-cholesterol Baseline to 1 year HDL-cholesterol changes: baseline to 1 year [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • changes in Apolipoprotein 4 (Apo4) and insulin sensitivity [ Time Frame: 1 year ]

Enrollment: 40
Study Start Date: September 2008
Study Completion Date: September 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Roux-en-Y gastric bypass
Both sexes, age between 30 and 60 years, BMI =/> 35 kg/m2
Procedure: Roux-en-Y gastric bypass
Active Comparator: Roux-en-Y gastric bypass
Active Comparator: diet and lifestyle modifications
Both sexes, age between 30 and 60 years, BMI =/> 35 kg/m2
Behavioral: diet and lifestyle modifications
Active Comparator: diet and lifestyle modifications

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI =/> 35 kg/m2,
  • age 30-60 years,
  • both sexes

Exclusion Criteria:

  • history of major abdominal or bariatric surgery,
  • disabling cardiac or pulmonary diseases,
  • cancer,
  • long-term treatment with oral corticosteroids, and
  • mental illness
  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): NCT01707771


Locations
Italy
Catholic University
Rome, Italy
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Geltrude Mingrone, MD Catholic University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Geltrude Mingrone, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01707771     History of Changes
Other Study ID Numbers: HDL-2008
First Submitted: October 10, 2012
First Posted: October 16, 2012
Last Update Posted: October 16, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms