Diabetes Prevention In Estrie

This study has been completed.
Sponsor:
Collaborators:
Ministère de la santé et des services sociaux du Québec
Novonordisk endocrine fellowship program
Information provided by:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00991549
First received: October 7, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 7, 2009
October 7, 2009
December 2004
October 2007   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Diabetes Prevention In Estrie
Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects

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.

Eligible participants will be randomized into 2 intervention groups (30 per group):

  1. 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.
  2. 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Overweight
  • Glucose Intolerance
Behavioral: interdisciplinary intervention or meeting-seminars
one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle
  • Experimental: 1
    interdisciplinary weight loss intervention
    Intervention: Behavioral: interdisciplinary intervention or meeting-seminars
  • Active Comparator: 2
    Small group seminars without interdisciplinary intervention
    Intervention: Behavioral: interdisciplinary intervention or meeting-seminars
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
January 2008
October 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00991549
04-087
No
Dr Marie-France Langlois, Universitaire de Sherbrooke
Université de Sherbrooke
  • Ministère de la santé et des services sociaux du Québec
  • Novonordisk endocrine fellowship program
Principal Investigator: Marie-France Langlois, MD Medecine department, Division of endocrinology, CHUS
Université de Sherbrooke
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP