Exercise Program Combined or Not With Nutritional intErvention in Adults With tyPe 2 Diabetes
PEP-2
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)
1 other identifier
interventional
90
1 country
1
Brief Summary
Inactivity and excess energy consumption are leading causes of obesity and type 2 diabetes which are associated with increased cardio-metabolic risk. In order to reduce the cardiovascular risk associated with type 2 diabetes, the Canadian Diabetes Association guidelines (2008) recommends weight loss through caloric restriction and structured physical activity. However, the comparative effects of different methods to obtain caloric deficit for weight loss remains to be elucidated. The main objective of this study is to assess the impact of two strategies of caloric deficit: diet alone or diet and exercise on total fat mass, epicardial fat and cardiovascular risk factors in overweight and obese adults with type 2 diabetes and at high risk of cardiovascular disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2010
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
First Submitted
Initial submission to the registry
August 20, 2010
CompletedFirst Posted
Study publicly available on registry
August 23, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedApril 19, 2016
April 1, 2016
5.6 years
August 20, 2010
April 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total fat mass
Total fat mass (kg) assessed by Dual X-Ray absoptiometry (DXA)
month 4
Secondary Outcomes (17)
Diabetes control
month 4
Epicardial fat
month 4
Body composition
month 4
Energy consumption
month 4
Resting metabolic rate
month 4
- +12 more secondary outcomes
Study Arms (3)
Optimized usual care
NO INTERVENTIONparticipants 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.
Diet intervention alone
ACTIVE COMPARATORParticipants 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.
diet intervention and exercise program
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) 27-40 kg/m2
- Type 2 diabetes diagnosed since at least 3 months
- High risk of cardiovascular disease : Framingham global cardiovascular risk score for 10 years \> 15% or 2 or more of the following risk factors: age \> 50years, dyslipidemia or treatment, high blood pressure or treatment, pathologic microalbuminuria or established proteinuria, currently smoking, family history of early cardiovascular disease (\< 60 years), inactivity or high waist circumference according to IDF criteria
- HbA1c : 6.0-10.0%
- Stable weight for last 3 months (±3kg) reported or documented
- Stable treatment for diabetes. 4 weeks: blood pressure and dyslipidemia medications. 3 months: glitazones and weight loss drugs the treatment that will be maintained at the same dose during the study; insulin will have been introduced since 4 months at least and previous month dose should be stable defined as a 10% variation or less of total daily units.
You may not qualify if:
- Pregnancy, breastfeeding
- Type 1 diabetes
- Secondary diabetes (e.g cystic fibrosis, steroid induced, etc.)
- Recurrent, hypoglycemia without precursor signs or severe hypoglycemia occurred ≥ 2 times for last 12 months
- Renal failure , creatinine clearance \< 40 ml/min (MDRD)
- Severe retinopathy or neuropathy that can contra-indicate exercise or expose patient to high risk of complications (e.g wound)
- NYHA classification class III or IV of cardiac insufficiency
- Established coronaropathy
- Non stable ventricular or supra-ventricular arrythmia
- Severe limb atherosclerosis or previous amputation
- Recent (\< 12 months) diagnosis of cancer excepted thyroid and skin
- Major mental disease
- Drugs with established effects on weigh such as megace®
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de recherches cliniques de Montréal (IRCM)
Montreal, Quebec, H2W 1R7, Canada
Related Publications (1)
Leroux-Stewart J, Elisha B, Tagougui S, Suppere C, Bernard S, Mircescu H, Desjardin K, Messier V, Iacobellis G, Rabasa-Lhoret R. Effect of caloric restriction with or without physical activity on body composition and epicardial fat in type 2 diabetic patients: A pilot randomized controlled trial. Nutr Metab Cardiovasc Dis. 2021 Mar 10;31(3):921-929. doi: 10.1016/j.numecd.2020.11.005. Epub 2020 Nov 13.
PMID: 33549453DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 20, 2010
First Posted
August 23, 2010
Study Start
September 1, 2010
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
April 19, 2016
Record last verified: 2016-04