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Completed

NCT Number: NCT00991549

Diabetes Prevention In Estrie

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.

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Key information

Conditions

Overweight Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interdisciplinary intervention or meeting-seminars

Behavioral

one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle

Primary outcomes

  1. a weight loss of 7% in at least 19% of the subjects

    Time frame: one year

  2. reduced body weight of at least 5.6 kg in at least 25% of the subjects

    Time frame: one year

  3. 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

  4. a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects

    Time frame: one year

  5. 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 outcomes

  1. change in insulin sensitivity by HOMA

    Time frame: one year

  2. change in insulin secretion during an OGTT by deconvolution of plasma c-peptide

    Time frame: one year

  3. change in beta cell function by calculation of the disposition index

    Time frame: one year

  4. change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT

    Time frame: one year

  5. 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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Ministere de la Sante et des Services Sociaux
  • Novonordisk endocrine fellowship program

Registry information

Official study title

Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Oct 8, 2009
Registry last updated
Oct 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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