Bariatric Surgery and HDL-cholesterol
Effect of Gastric Bypass Versus Diet on Cardiovascular Risk Factors
1 other identifier
interventional
40
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 10, 2012
CompletedFirst Posted
Study publicly available on registry
October 16, 2012
CompletedOctober 16, 2012
October 1, 2012
3 years
October 10, 2012
October 15, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
changes in HDL-cholesterol Baseline to 1 year HDL-cholesterol changes: baseline to 1 year
1 year
Secondary Outcomes (1)
changes in Apolipoprotein 4 (Apo4) and insulin sensitivity
1 year
Study Arms (2)
Roux-en-Y gastric bypass
ACTIVE COMPARATORBoth sexes, age between 30 and 60 years, BMI =/\> 35 kg/m2
diet and lifestyle modifications
ACTIVE COMPARATORBoth sexes, age between 30 and 60 years, BMI =/\> 35 kg/m2
Interventions
Active Comparator: Roux-en-Y gastric bypass
Active Comparator: diet and lifestyle modifications
Eligibility Criteria
You may qualify if:
- BMI =/\> 35 kg/m2,
- age 30-60 years,
- both sexes
You may not qualify if:
- history of major abdominal or bariatric surgery,
- disabling cardiac or pulmonary diseases,
- cancer,
- long-term treatment with oral corticosteroids, and
- mental illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic University
Rome, Italy
Related Publications (1)
Raffaelli M, Guidone C, Callari C, Iaconelli A, Bellantone R, Mingrone G. Effect of gastric bypass versus diet on cardiovascular risk factors. Ann Surg. 2014 Apr;259(4):694-9. doi: 10.1097/SLA.0b013e31829d6989.
PMID: 23979288DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geltrude Mingrone, MD
Catholic University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 10, 2012
First Posted
October 16, 2012
Study Start
September 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2012
Last Updated
October 16, 2012
Record last verified: 2012-10