Exercise Program Combined or Not With Nutritional intErvention in Adults With tyPe 2 Diabetes (PEP-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01186952
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : April 19, 2016
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Total fat mass [ Time Frame: month 4 ]
    Total fat mass (kg) assessed by Dual X-Ray absoptiometry (DXA)

Secondary Outcome Measures :
  1. Diabetes control [ Time Frame: month 4 ]
    A1c and fasting plasma glucose

  2. Epicardial fat [ Time Frame: month 4 ]
    Epicardial fat thickness measured by simplified cardiac echography

  3. 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

  4. 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.

  5. Resting metabolic rate [ Time Frame: month 4 ]
    Resting metabolic rate determined by indirect calorimetry.

  6. Total energy expenditure [ Time Frame: month 2,3,4 ]
    Total energy expenditure estimated from 7 days accelerometer data (Senwear Armband accelerometer).

  7. Physical activity energy expenditure [ Time Frame: month 2,3,4 ]
    Physical activity energy expenditure estimated from 7 days accelerometer data (Senwear Armband accelerometer).

  8. Muscle strength [ Time Frame: month 4 ]
    upper and lower body strength using 1-RM technique

  9. 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.

  10. 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

  11. Biochemical hepatic steatosis score [ Time Frame: month 4 ]
  12. Blood pressure [ Time Frame: month 4 ]
    systolic and diastolic blood pressure

  13. Hormonal profile [ Time Frame: month 4 ]
  14. Inflammatory profile [ Time Frame: month 4 ]
  15. 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

  16. Diabetes self-care [ Time Frame: month 4 ]
    Summary of diabetes care activities (SDCA) questionnaire

  17. visceral fat thickness [ Time Frame: month 4 ]

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01186952

Canada, Quebec
Institut de recherches cliniques de Montréal (IRCM)
Montreal, Quebec, Canada, H2W 1R7
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
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

Responsible Party: Rémi Rabasa-Lhoret, MD, PhD, Institut de Recherches Cliniques de Montreal Identifier: NCT01186952     History of Changes
Other Study ID Numbers: RRL-01-2010
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal:
type 2 diabetes
caloric restriction
exercise program
epicardial fat

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms