Bariatric Surgery and HDL-cholesterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geltrude Mingrone, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01707771
First received: October 10, 2012
Last updated: October 15, 2012
Last verified: October 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in Apolipoprotein 4 (Apo4) and insulin sensitivity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Catholic University of the Sacred Heart

Additional 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
Study First Received: October 10, 2012
Last Updated: October 15, 2012
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on August 21, 2014