Long-term Benefits of Abdominal Fat Loss in Abdominally Obese Dyslipidemic Patients (SYNERGIE Study)

NCT06158191 | Completed

• 1 other identifier: SYNERGIE Study
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity, Visceral; Diet, Healthy; Cardiometabolic Syndrome; Lifestyle-related Condition

Keywords

Cardiometabolic health; Physical activity; Diet; Visceral obesity; Lifestyle intervention; Cardiorespiratory fitness

Outcome Measures

Primary Outcomes (6)

• Changes in body weight following the lifestyle intervention and the maintenance period using dual-energy x-ray absorptiometry

  Changes in body weight in kilograms

  After the 1-year intervention and at 3 years after the beginning of the study

• Changes in visceral adipose tissue area following the lifestyle intervention and the maintenance period using computed tomography

  Changes in visceral adipose tissue area in centimeters²

  After the 1-year intervention and at 3 years after the beginning of the study

• Changes in visceral adipose tissue volume following the lifestyle intervention and the maintenance period using computed tomography

  Changes in visceral adipose tissue volume in centimeters³

  After the 1-year intervention and at 3 years after the beginning of the study

• Changes in waist circumference following the lifestyle intervention and the maintenance period using a standardized measuring tape

  Changes in waist circumference in centimeters

  After the 1-year intervention and at 3 years after the beginning of the study

• Changes in subcutaneous adipose tissue area following the lifestyle intervention and the maintenance period

  Changes in subcutaneous adipose tissue area in centimeters²

  After the 1-year intervention and at 3 years after the beginning of the study

• Changes in subcutaneous adipose tissue volume following the lifestyle intervention and the maintenance period

  Changes in subcutaneous adipose tissue volume in centimeters³

  After the 1-year intervention and at 3 years after the beginning of the study

Secondary Outcomes (20)

• Changes in systolic blood pressure following the lifestyle intervention and the maintenance period

  After the 1-year intervention and at 3 years after the beginning of the study

• Changes in diastolic blood pressure following the lifestyle intervention and the maintenance period

  After the 1-year intervention and at 3 years after the beginning of the study

• Changes in plasma triglycerides following the lifestyle intervention and the maintenance period

  After the 1-year intervention and at 3 years after the beginning of the study

• Changes in fasting total cholesterol following the lifestyle intervention and the maintenance period

  After the 1-year intervention and at 3 years after the beginning of the study

• Changes in fasting HDL cholesterol following the lifestyle intervention and the maintenance period

  After the 1-year intervention and at 3 years after the beginning of the study

Study Arms (2)

Intervention group

EXPERIMENTAL

Lifestyle modification program focused on physical activity and diet. Diet recommendations in line with the AHA's guidelines focusing on foods rather than nutrients. Emphasis will be placed on awareness of the risk of overeating associated with the consumption of energy-dense foods (fat, added sugar or both). Dieticians will closely interact with participants and will not recommend a daily energy deficit greater than 500 kcal. Participants will have constant access to the dieticians and bi-monthly appointment will be required for the first year of the study to tailor recommendations to the participants. The physical activity/exercise component will be under the supervision of a kinesiologist and will aim at 160 minutes per week of moderate intensity endurance-exercise (mainly brisk walking) tailored to the participants' preferences and habits. Following the first year, participants will meet a dietician and a kinesiologist every month for the next two years (maintenance period).

Behavioral: Lifestyle modification program

Control group

NO INTERVENTION

Usual behavior

Interventions

Lifestyle modification program BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index between 25 kilograms/meters² and 40 kilograms/meters²
• Waist circumference ≥ 90 centimeters and triglycerides ≥ 2.0 milimoles/liter or HDL \< 1.03 milimoles/liter

You may not qualify if:

• Pharmacological treatment for hypertension, dyslipidemias, type 2 diabetes, coronary heart disease, or cardiovascular disease
• Type 2 diabetes diagnosis at baseline screening
• Use of weight loss medication in the past 6 months

Sponsors & Collaborators

• Laval University: lead

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  BACKGROUND

MeSH Terms

Conditions

Obesity, Abdominal; Metabolic Syndrome; Mental Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior

Study Officials

• Jean-Pierre Després, Ph.D.

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention group and control group

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 6, 2023
• Study Start: March 26, 2004
• Primary Completion: December 15, 2008
• Study Completion: December 15, 2008
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share