CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 186 enrolled
Drug / intervention
Lifestyle modification programbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06158191
NCT06158191N/ACompleted

Abdominal Obesity as a Therapeutic Target: Long-term Benefits of Abdominal Fat Loss and Weight Stabilization in High-risk Abdominally Obese Dyslipidemic Patients With the Features of the Metabolic Syndrome (SYNERGIE Study)

Laval University·interventional·Posted Dec 6, 2023·Updated Dec 6, 2023

In Brief

A clinical study evaluating Lifestyle modification program for Obesity, Visceral and 3 related conditions. Completed, enrolled 186 participants.

Detailed Summary

The objective of this clinical trial is to verify whether the beneficial effects of weight loss on visceral fat measured by computed tomography and metabolic risk factors for coronary heart disease are maintained once high-risk patients without symptoms and with visceral obesity and dyslipidemia are stabilized and maintained for two additional years after a one-year weight loss (5-10%) program. Before entering the study, after the one-year intervention program, and after the 2-year maintenance period, participants will be asked to take part in multiple assessments: fasting lipid profile and apolipoproteins measurements, oral glucose tolerance test, anthropometric measurements, computed tomography, dual-energy X-ray absorptiometry, oral lipid tolerance test, measurements of inflammatory markers, physical activity and dietary diaries, cardiorespiratory fitness assessed by a submaximal treadmill test, and measurements of resting and exercise blood pressure. During the one-year intervention, participants will be closely monitored by the study's dietitians and kinesiologists to achieve the target weight loss. Dieticians will not recommend a daily energy deficit greater than 500 calories and will focus on foods rather than the nutrient composition of the diet. Participants will have access to the dieticians at all time, and appointments every two months will be required during the first year. Regarding physical activity, kinesiologists will supervise the exercise prescription which will aim at 160 minutes per week of moderate-intensity aerobic-exercise. The physical activity prescription will be adjusted by the kinesiologist according to the participant's preferences and habits. The investigators hypothesize that there will be a worsening in some features of the metabolic syndrome over the two-year weight maintenance period. However, it is suggested the greater the weight loss during the intervention, the less marked the deterioration will be. Finally, the investigators put forward that even in the absence of weight loss during the intervention, the lifestyle modification program will prevent visceral fat accumulation expected to be observed over the two-year maintenance period in the control group maintaining their usual behaviour.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 6, 2023
Enrollment StartMar 26, 2004
Primary CompletionDec 15, 2008
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 2.6 years ago

Interventions

Lifestyle modification programbehavioral

Participants will take part in a lifestyle modification program focused on physical activity and diet.