Diabetes Prevention In Estrie

This study has been completed.
Sponsor:
Collaborators:
Ministere de la Sante et des Services Sociaux
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
  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

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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):

  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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00991549

Locations
Canada, Quebec
Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Sponsors and Collaborators
Université de Sherbrooke
Ministere de la Sante et des Services Sociaux
Novonordisk endocrine fellowship program
Investigators
Principal Investigator: Marie-France Langlois, MD Medecine department, Division of endocrinology, CHUS
  More Information

No publications provided by Université 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 Université de Sherbrooke:
overweight
obesity
glucose intolerance
pre-diabetes

Additional relevant MeSH terms:
Overweight
Glucose Intolerance
Body Weight
Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 22, 2014