OverweightPEP-2NCT01186952
Exercise Program Combined or Not With Nutritional intErvention in Adults With tyPe 2 Diabetes
A study testing Caloric restriction and Diet intervention and structured exercise training program in people with Overweight and Obesity, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Overweight, Obesity, Type 2 Diabetes
- What is being tested?
- Caloric restriction and Diet intervention and structured exercise training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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®
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal (IRCM)
Montreal, Quebec, H2W 1R7
About this study
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)
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.
Read the 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.
- Conditions
- Overweight, Obesity, Type 2 Diabetes
- Being tested
- Caloric restriction, Diet intervention and structured exercise training program
- Keywords
- overweight, obesity, type 2 diabetes, caloric restriction, exercise program, epicardial fat
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric restrictionBehavioural
Also called Structured diet intervention (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.
Diet intervention and structured exercise training programBehavioural
Also called diet intervention and exercise 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.
| Study group | Role | What they receive |
|---|---|---|
| Optimized usual care | No intervention | 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. |
| Diet intervention alone | Active comparator | 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. Receives: Behavioral: Caloric restriction |
| diet intervention and exercise program | Active comparator | 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. Receives: Behavioral: Diet intervention and structured exercise training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fat mass
Total fat mass (kg) assessed by Dual X-Ray absoptiometry (DXA)
Measured: month 4
Secondary outcomes (17)
Diabetes control
A1c and fasting plasma glucose
Measured: month 4
Epicardial fat
Epicardial fat thickness measured by simplified cardiac echography
Measured: month 4
Body composition
Body composition : trunkal fat mass, apendicular fat mass, lean body mass and estimated visceral fat mass determined by DXA
Measured: month 4
Energy consumption
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.
Measured: month 4
Resting metabolic rate
Resting metabolic rate determined by indirect calorimetry.
Measured: month 4
Total energy expenditure
Total energy expenditure estimated from 7 days accelerometer data (Senwear Armband accelerometer).
Measured: month 2,3,4
Physical activity energy expenditure
Physical activity energy expenditure estimated from 7 days accelerometer data (Senwear Armband accelerometer).
Measured: month 2,3,4
Muscle strength
upper and lower body strength using 1-RM technique
Measured: month 4
Cardiorespiratory fitness
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.
Measured: month 4
Lipid profile
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
Measured: month 4
Biochemical hepatic steatosis score
Measured: month 4
Blood pressure
systolic and diastolic blood pressure
Measured: month 4
Hormonal profile
Measured: month 4
Inflammatory profile
Measured: month 4
Psychosocial profile
questionnaire addressing : body esteem, self-esteem, stress, dietary restraint, disinhibition, hunger, quality of life, self-efficacy,perceived benefits, perceived risks
Measured: month 4
Diabetes self-care
Summary of diabetes care activities (SDCA) questionnaire
Measured: month 4
visceral fat thickness
Measured: month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Remi Rabasa-Lhoret, MD, PhD, Principal investigator, Institut de Recherches Cliniques de MontrealAntony Karelis, PhD, Study chair, Université de Québec à MontréalDenis Prud'Homme, MD, Msc, Study chair, University of OttawaEric Doucet, PhD, Study chair, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186952
- Sponsor's protocol ID
- RRL-01-2010
- Acronym
- PEP-2
- Status last verified
- Apr 2016
- First submitted
- 20 Aug 2010
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33549453
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01186952
- Acronym / sponsor ID
- PEP-2 / RRL-01-2010
- Conditions
- Overweight, Obesity, Type 2 Diabetes
- Keywords
- overweight, obesity, type 2 diabetes, caloric restriction, exercise program, epicardial fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Optimized usual care | No intervention | –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. |
| Diet intervention alone | Active comparator | Behavioral: Caloric restrictionParticipants 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 comparator | Behavioral: Diet intervention and structured exercise training programParticipants 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric restrictionAlso: Structured diet intervention (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. | Behavioural | Diet intervention alone |
| Diet intervention and structured exercise training programAlso: diet intervention and exercise 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. | Behavioural | diet intervention and exercise program |
Primary outcome
Total fat mass
Time frame: month 4
Total fat mass (kg) assessed by Dual X-Ray absoptiometry (DXA)
17 secondary outcomes
Diabetes control
Time frame: month 4
Epicardial fat
Time frame: month 4
Body composition
Time frame: month 4
Energy consumption
Time frame: month 4
Resting metabolic rate
Time frame: month 4
Total energy expenditure
Time frame: month 2,3,4
Physical activity energy expenditure
Time frame: month 2,3,4
Muscle strength
Time frame: month 4
Cardiorespiratory fitness
Time frame: month 4
Lipid profile
Time frame: month 4
Biochemical hepatic steatosis score
Time frame: month 4
Blood pressure
Time frame: month 4
Hormonal profile
Time frame: month 4
Inflammatory profile
Time frame: month 4
Psychosocial profile
Time frame: month 4
Diabetes self-care
Time frame: month 4
visceral fat thickness
Time frame: month 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Derived from this study: PubMed 33549453Leroux-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remi Rabasa-Lhoret, MD, PhD principal investigator
Institut de Recherches Cliniques de Montreal
Antony Karelis, PhD study chair
Université de Québec à Montréal
Denis Prud'Homme, MD, Msc study chair
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric restriction and Diet intervention and structured exercise training program in people with Overweight and Obesity, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fat mass (time frame: month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.