Exercise Program Combined or Not With Nutritional intErvention in Adults With tyPe 2 Diabetes (PEP-2)
|ClinicalTrials.gov Identifier: NCT01186952|
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : April 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity Type 2 Diabetes||Behavioral: Caloric restriction Behavioral: Diet intervention and structured exercise training program||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of an Exercise Program Combined or Not With Nutritional intErvention on Total Fat, Epicardial Fat and Metabolic Profile of Obese and Overweight Adults With tyPe 2 Diabetes (The PEP-2 Study)|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
No Intervention: Optimized usual care
participants will attend one visit with the dietician (30mn) and the physical activity specialist (30mn) when they will be given Canadian guidelines pamphlets for physical activity and food consumption. They will also receive a phone call once a month to discuss about issues in guidelines following.
Active Comparator: Diet intervention alone
Participants will attend one visit with the physical activity specialist (30mn) when they will receive the physical activity guidelines. Monthly phone call will be make to discuss about issues in physical activity guidelines following.These individuals will also be enrolled in a supervised caloric restriction program. They will have to visit the dietician once a week for the first months and then twice a month for 3 months. The diet intervention will focus on a low fat diet. At each session participants will be weighed and taken the blood pressure.
Behavioral: Caloric restriction
The caloric restriction diet will follow the Canadian Diabetes Association guidelines and be nutritionally balanced with a reduced total fat as well as saturated content.
Other Name: Structured diet intervention (caloric restriction)
Active Comparator: diet intervention and exercise program
Participants will attend diet intervention as described for group 2. They will also follow a supervised exercise program three days per week for 4 months. The exercise training is an interval high intensity aerobic (85-90% heart rate reserve) program with resistance exercises (15RM, 2-3 repetitions). Each session will last one hour. At the end of month 1, 2, and 3, all participants will receive the SWA armband for 7 days to record physical activity and estimate energy expenditure.
At the end of Month 4, all participants will attend a study visit for repeat baseline testing.
Behavioral: Diet intervention and structured exercise training program
Participants will follow the diet intervention previously described and a supervised physical activity program. The supervised exercise training sessions will take place three times a week for 4 months. Each session will last 1hour and will include aerobic exercise and resistance training. The aerobic training program will be treadmills intervals exercise at 50-70 % of heart rate reserve(HRR) the first month and 85-90% of HRR from the second to the fourth month. The resistance training programme will consist of two to three sets of 12 repetitions of the following exercises: leg press, chest press, lat pulldown, shoulder press, biceps curl, triceps extension.
Other Name: diet intervention and exercise program.
- Total fat mass [ Time Frame: month 4 ]Total fat mass (kg) assessed by Dual X-Ray absoptiometry (DXA)
- Diabetes control [ Time Frame: month 4 ]A1c and fasting plasma glucose
- Epicardial fat [ Time Frame: month 4 ]Epicardial fat thickness measured by simplified cardiac echography
- Body composition [ Time Frame: month 4 ]Body composition : trunkal fat mass, apendicular fat mass, lean body mass and estimated visceral fat mass determined by DXA
- Energy consumption [ Time Frame: month 4 ]Energy consumption : as measured by total calories consumed using a three non consecutive days food journal. The three days should include one week-end day.
- Resting metabolic rate [ Time Frame: month 4 ]Resting metabolic rate determined by indirect calorimetry.
- Total energy expenditure [ Time Frame: month 2,3,4 ]Total energy expenditure estimated from 7 days accelerometer data (Senwear Armband accelerometer).
- Physical activity energy expenditure [ Time Frame: month 2,3,4 ]Physical activity energy expenditure estimated from 7 days accelerometer data (Senwear Armband accelerometer).
- Muscle strength [ Time Frame: month 4 ]upper and lower body strength using 1-RM technique
- Cardiorespiratory fitness [ Time Frame: month 4 ]Participants will perform a graded exercise test on a cycle ergometer to voluntary exhaustion. Peak oxygen consumption (VO2peak) will be considered to be the highest value obtained during the test.
- Lipid profile [ Time Frame: month 4 ]Total cholesterol, LDL-Cholesterol, HDL-cholesterol (HDL-C), Triglycerides, Apolipoprotein B, ratios TG/HDL-C and Total cholesterol/HDL-C will be determined with fasting veinous blood sample
- Biochemical hepatic steatosis score [ Time Frame: month 4 ]
- Blood pressure [ Time Frame: month 4 ]systolic and diastolic blood pressure
- Hormonal profile [ Time Frame: month 4 ]
- Inflammatory profile [ Time Frame: month 4 ]
- Psychosocial profile [ Time Frame: month 4 ]questionnaire addressing : body esteem, self-esteem, stress, dietary restraint, disinhibition, hunger, quality of life, self-efficacy,perceived benefits, perceived risks
- Diabetes self-care [ Time Frame: month 4 ]Summary of diabetes care activities (SDCA) questionnaire
- visceral fat thickness [ Time Frame: month 4 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186952
|Institut de recherches cliniques de Montréal (IRCM)|
|Montreal, Quebec, Canada, H2W 1R7|
|Principal Investigator:||Remi Rabasa-Lhoret, MD, PhD||Institut de Recherches Cliniques de Montreal|
|Study Chair:||Antony Karelis, PhD||Université de Québec à Montréal|
|Study Chair:||Denis Prud'Homme, MD, Msc||University of Ottawa|
|Study Chair:||Eric Doucet, PhD||University of Ottawa|