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Bariatric Surgery and HDL-cholesterol

NCT01707771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-10-16

No results posted yet for this study

Summary

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).

Conditions

  • Morbid Obesity

Interventions

PROCEDURE

Roux-en-Y gastric bypass

Active Comparator: Roux-en-Y gastric bypass

BEHAVIORAL

diet and lifestyle modifications

Active Comparator: diet and lifestyle modifications

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Geltrude Mingrone, MD · Catholic University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-09-30
Completion
2012-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01707771 on ClinicalTrials.gov