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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Institut de Recherches Cliniques de Montreal
Sponsor:
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier:
NCT01186952
First received: August 20, 2010
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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 Intervention
Overweight
Obesity
Type 2 Diabetes
Behavioral: Caloric restriction
Behavioral: Diet intervention and structured exercise training program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Institut de Recherches Cliniques de Montreal:

Primary Outcome Measures:
  • Total fat mass [ Time Frame: month 4 ] [ Designated as safety issue: No ]
    Total fat mass (kg) assessed by Dual X-Ray absoptiometry (DXA)


Secondary Outcome Measures:
  • Diabetes control [ Time Frame: month 4 ] [ Designated as safety issue: No ]
    A1c and fasting plasma glucose

  • Epicardial fat [ Time Frame: month 4 ] [ Designated as safety issue: No ]
    Epicardial fat thickness measured by simplified cardiac echography

  • Body composition [ Time Frame: month 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Resting metabolic rate determined by indirect calorimetry.

  • Total energy expenditure [ Time Frame: month 2,3,4 ] [ Designated as safety issue: No ]
    Total energy expenditure estimated from 7 days accelerometer data (Senwear Armband accelerometer).

  • Physical activity energy expenditure [ Time Frame: month 2,3,4 ] [ Designated as safety issue: No ]
    Physical activity energy expenditure estimated from 7 days accelerometer data (Senwear Armband accelerometer).

  • Muscle strength [ Time Frame: month 4 ] [ Designated as safety issue: No ]
    upper and lower body strength using 1-RM technique

  • Cardiorespiratory fitness [ Time Frame: month 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: month 4 ] [ Designated as safety issue: No ]
    systolic and diastolic blood pressure

  • Hormonal profile [ Time Frame: month 4 ] [ Designated as safety issue: No ]
  • Inflammatory profile [ Time Frame: month 4 ] [ Designated as safety issue: No ]
  • Psychosocial profile [ Time Frame: month 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Summary of diabetes care activities (SDCA) questionnaire

  • visceral fat thickness [ Time Frame: month 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Hide Detailed Description

Detailed Description:

Type 2 diabetes is mainly caused by excess body weight due to lack of physical activity and high amount of calories consumption. Individuals with type 2 diabetes demonstrated increased risk of cardiovascular disease compared to non diabetic. Studies showed a cardiovascular risk reduction after weight loss among individuals at risk through lifestyle modification: increase physical activity and low calorie diet.

Favourable effects of weight loss on cardiovascular risk are mainly due to total body fat reduction. However, the location of body fat excess has also some important implications. It is now well known that abdominal (visceral) and ectopic fat accumulation (e.g. hepatic fat, epicardial fat, etc.) are more related to an unfavorable cardio-metabolic profile than total fat mass. It has been demonstrated that a moderate weight loss obtained with physical activity or caloric restriction is related to a significant reduction of ectopic fat mass. However, ectopic fat measurement remains problematic due to lack of standardization and safety issues (X-ray). Epicardial fat thickness measured by simple echocardiography is a reliable method to evaluate ectopic fat accumulation.

Little research have been done to assess the effect of different methods of weight loss on total fat as well as ectopic fat specifically epicardial adipose tissue among individuals with type 2 diabetes. The objective of this study is to compare to a control group with detailed advice the impact of two structured 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.

The participants to the present study will be free-living adults overweight and obese with type 2 diabetes and at high risk of cardiovascular disease as determined by a Framingham risk score above 15% or the presence of two or more cardiovascular risk factors.

Participants will attend a screening study visit to confirm eligibility criteria (anthropometric variables, blood pressure, complete physical examination, coronary heart disease diagnostic by echocardiogram, physical activity aptitude).

After enrollment, a baseline visit will consist in series of data collection such as : anthropometric variables, blood pressure, cycle ergometer test to evaluate cardiovascular fitness, an echocardiography to determine epicardial fat thickness, a dual energy x-ray absorptiometry (DEXA) scan to assess body fat, lean mass and bone density, indirect calorimetry for resting metabolic rate, physical activity profile and total energy expenditure determined by Sense Wear Armband (SWA) accelerometer (7days), food consumption estimate with 3 days dairy, questionnaires addressing sociodemographic and psychosocial characteristics, diabetes self-care (SDCA questionnaire), a blood and urine collection for diabetes control, hepatic steatosis biochemical score, detailed lipids, hormonal and inflammatory profile and finally microalbuminuria. The body composition will also be measured by impedancemetry and BOD-POD.

Participants will then be randomly assigned to one of the three groups of the study :

Group 1: Counseling for physical activity and healthy eating Group 2: Structured diet intervention (caloric restriction) and counseling for physical activity Group 3: Structured diet intervention (caloric restriction) and structured exercise training program (aerobic and resistance training).

Group 1: 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.

Group 2: 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.

Group 3: 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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186952

Contacts
Contact: Annie Tardif 514-987-3318 annie.tardif@ircm.qc.ca
Contact: Belinda Elisha, Msc 514 987 5500 ext 3238 belinda.elisha@ircm.qc.ca

Locations
Canada, Quebec
Institut de recherches cliniques de Montréal (IRCM) Recruiting
Montreal, Quebec, Canada, H2W 1R7
Contact: Annie Tardif    514-987-3318    annie.tardif@ircm.qc.ca   
Contact: Belinda Elisha, Msc    514-987-5500 ext 3238    belinda.elisha@ircm.qc.ca   
Principal Investigator: Remi Rabasa-Lhoret, MD, PhD         
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Investigators
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
  More Information

No publications provided

Responsible Party: Rémi Rabasa-Lhoret, MD, PhD, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT01186952     History of Changes
Other Study ID Numbers: RRL-01-2010
Study First Received: August 20, 2010
Last Updated: May 6, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Institut de Recherches Cliniques de Montreal:
overweight
obesity
type 2 diabetes
caloric restriction
exercise program
epicardial fat

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

ClinicalTrials.gov processed this record on October 29, 2014