Diabetes Prevention In Estrie
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Purpose
This study compared the efficacy at one year of an interdisciplinary approach including individual counseling and group seminars versus group seminars alone to induce weight loss in subjects at high risk of developing type 2 diabetes.
This study also compare if a participant's presence in small informative meeting groups as the only form of intervention is sufficient to induce a lifestyle change, thus inducing the weight loss needed for the prevention of the diseases associated with obesity.
| Condition | Intervention |
|---|---|
|
Overweight Glucose Intolerance |
Behavioral: interdisciplinary intervention or meeting-seminars |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects |
- a weight loss of 7% in at least 19% of the subjects [ Time Frame: one year ] [ Designated as safety issue: No ]
- reduced body weight of at least 5.6 kg in at least 25% of the subjects [ Time Frame: one year ] [ Designated as safety issue: No ]
- an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects [ Time Frame: one year ] [ Designated as safety issue: No ]
- a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects [ Time Frame: one year ]
- a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects [ Time Frame: one year ] [ Designated as safety issue: No ]
- change in insulin sensitivity by HOMA [ Time Frame: one year ] [ Designated as safety issue: No ]
- change in insulin secretion during an OGTT by deconvolution of plasma c-peptide [ Time Frame: one year ] [ Designated as safety issue: No ]
- change in beta cell function by calculation of the disposition index [ Time Frame: one year ] [ Designated as safety issue: No ]
- change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT [ Time Frame: one year ] [ Designated as safety issue: No ]
- relation between weight loss and change in insulin sensitivity, beta cell function, and insulin-mediated suppression of plasma non-esterified fatty acids [ Time Frame: one year ] [ Designated as safety issue: No ]
| Enrollment: | 53 |
| Study Start Date: | December 2004 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
interdisciplinary weight loss intervention
|
Behavioral: interdisciplinary intervention or meeting-seminars
one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle
|
|
Active Comparator: 2
Small group seminars without interdisciplinary intervention
|
Behavioral: interdisciplinary intervention or meeting-seminars
one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle
|
Detailed Description:
Eligible participants will be randomized into 2 intervention groups (30 per group):
- Small Meeting groups: a curriculum of 25 meeting-seminars will take place for 45 minutes, each one approaching various aspects of nutrition, physical activity, psychology, motivation and medical needs. These seminars are administered by the professionals of the obesity clinic and are already in place. However, these are usually only offered to the patients registered with the obesity clinic.
- Obesity Clinic of CHUS: combination of 25 described meeting-seminars see-high, in addition to individual interviews every 6 weeks with the interdisciplinary team of the obesity clinic of CHUS (usual operation).
Subjects will be evaluated initially and then every 3 months during 1 year by the following measurements: questionnaires to evaluate motivation and physical activity; 3 day dietary journals; weight assessment, using both metabolic and mechanical balance; waist circumference; and blood pressure.
A medical evaluation with size measure, a test evaluating knowledge of the participants on obesity, OGTT (Oral Glucose Tolerance Test) - a 5 hour determination of secretion and resistance to insulin, insulin-mediated suppression of plasma non-esterified fatty acids, a plasma lipid profile, accelerometry, bio electric impedance, and an activity physical test (6 minute walk test) will be carried out initially, and then repeated for up to 1 year.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- pre diabetic state underlined by a marginal fasting glycemia between 6,1 and 6,9 mmol/L and/or a glucose intolerance with glucose confirmed by an OGTT 2 hours
- overweight or obesity (BMI > 27 kg/m² ; (Body Mass Index))
- enlightened assent
Exclusion Criteria:
- Impossibility to be present at the visits
- Physical/motor incapacity (or other) making one unable and/or insecure to walk at a moderate to rapid speed of 6 min and more
- Use of an anti-obesity treatment during the last 3 months
- Bariatric Surgery in the past
- Planned Pregnancy
- Pacemaker
Contacts and Locations| Canada, Quebec | |
| Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke | |
| Sherbrooke, Quebec, Canada | |
| Principal Investigator: | Marie-France Langlois, MD | Medecine department, Division of endocrinology, CHUS |
More Information
No publications provided by Universitaire de Sherbrooke
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Marie-France Langlois, Universitaire de Sherbrooke |
| ClinicalTrials.gov Identifier: | NCT00991549 History of Changes |
| Other Study ID Numbers: | 04-087 |
| Study First Received: | October 7, 2009 |
| Last Updated: | October 7, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Universitaire de Sherbrooke:
|
overweight obesity glucose intolerance pre-diabetes |
Additional relevant MeSH terms:
|
Glucose Intolerance Overweight Hyperglycemia Glucose Metabolism Disorders |
Metabolic Diseases Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013