Diabetes Prevention In Estrie
Primary Purpose
Overweight, Glucose Intolerance
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
interdisciplinary intervention or meeting-seminars
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring overweight, obesity, glucose intolerance, pre-diabetes
Eligibility Criteria
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
Sites / Locations
- Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
interdisciplinary weight loss intervention
Small group seminars without interdisciplinary intervention
Outcomes
Primary Outcome Measures
a weight loss of 7% in at least 19% of the subjects
reduced body weight of at least 5.6 kg in at least 25% of the subjects
an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects
a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects
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
Secondary Outcome Measures
change in insulin sensitivity by HOMA
change in insulin secretion during an OGTT by deconvolution of plasma c-peptide
change in beta cell function by calculation of the disposition index
change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT
relation between weight loss and change in insulin sensitivity, beta cell function, and insulin-mediated suppression of plasma non-esterified fatty acids
Full Information
NCT ID
NCT00991549
First Posted
October 7, 2009
Last Updated
October 7, 2009
Sponsor
Université de Sherbrooke
Collaborators
Ministere de la Sante et des Services Sociaux, Novonordisk endocrine fellowship program
1. Study Identification
Unique Protocol Identification Number
NCT00991549
Brief Title
Diabetes Prevention In Estrie
Official Title
Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Université de Sherbrooke
Collaborators
Ministere de la Sante et des Services Sociaux, Novonordisk endocrine fellowship program
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Glucose Intolerance
Keywords
overweight, obesity, glucose intolerance, pre-diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
interdisciplinary weight loss intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Small group seminars without interdisciplinary intervention
Intervention Type
Behavioral
Intervention Name(s)
interdisciplinary intervention or meeting-seminars
Intervention Description
one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle
Primary Outcome Measure Information:
Title
a weight loss of 7% in at least 19% of the subjects
Time Frame
one year
Title
reduced body weight of at least 5.6 kg in at least 25% of the subjects
Time Frame
one year
Title
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
Title
a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects
Time Frame
one year
Title
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
Secondary Outcome Measure Information:
Title
change in insulin sensitivity by HOMA
Time Frame
one year
Title
change in insulin secretion during an OGTT by deconvolution of plasma c-peptide
Time Frame
one year
Title
change in beta cell function by calculation of the disposition index
Time Frame
one year
Title
change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT
Time Frame
one year
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-France Langlois, MD
Organizational Affiliation
Medecine department, Division of endocrinology, CHUS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21489843
Citation
Gagnon C, Brown C, Couture C, Kamga-Ngande CN, Hivert MF, Baillargeon JP, Carpentier AC, Langlois MF. A cost-effective moderate-intensity interdisciplinary weight-management programme for individuals with prediabetes. Diabetes Metab. 2011 Nov;37(5):410-8. doi: 10.1016/j.diabet.2011.01.003. Epub 2011 Apr 13.
Results Reference
derived
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Diabetes Prevention In Estrie
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