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Lifestyle Intervention in Individuals With Low or High Genetic Risk for Type 2 Diabetes (T2D-GENE)

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ClinicalTrials.gov Identifier: NCT02709057
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Markku Laakso, University of Eastern Finland

Brief Summary:
The aim of the study is to compare the effect of lifestyle intervention (diet and physical activity) by applying modern approaches to lifestyle changes on the prevention of incident T2DM and the worsening of hyperglycemia in people with high number of T2DM risk alleles and in people with low number of T2DM risk alleles compared to corresponding control groups.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Lifestyle intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Lifestyle Intervention on Incident Diabetes in Individuals With Impaired Fasting Glucose and Low or High Genetic Risk for the Development of Type 2 Diabetes
Study Start Date : April 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Life-style intervention 1
Life-style intervention in participants with low genetic risk score: The 3-year lifestyle intervention includes 7-9 group sessions (two additional group sessions for participants whose body mass index exceeds 28 kg/m2) on diet (healthy diet according to Nordic and Finnish nutrition recommendations emphasizing appropriate energy intake, meal frequency, consumption of fruits, vegetables and berries, quality of dietary fat and carbohydrates, including sugar and fiber intake) and physical exercise (brisk walking a minimum of 30 minutes per day at least five days a week or other types of exercise, e.g. cycling, cross-country skiing, housework such as leafs raking, resistance training).
Behavioral: Lifestyle intervention
Life-style intervention includes 7-9 group sessions (two additional group sessions for participants whose body mass index exceeds 28 kg/m2) on diet (healthy diet according to Nordic and Finnish nutrition recommendations emphasizing appropriate energy intake, meal frequency, consumption of fruits, vegetables and berries, quality of dietary fat and carbohydrates, including sugar and fiber intake) and physical exercise (brisk walking a minimum of 30 minutes per day at least five days a week or other types of exercise, e.g. cycling, cross-country skiing, housework such as leafs raking, resistance training).
Active Comparator: Life-style intervention 2
Life-style intervention in participants with high genetic risk score: The 3-year lifestyle intervention includes 7-9 group sessions (two additional group sessions for participants whose body mass index exceeds 28 kg/m2) on diet (healthy diet according to Nordic and Finnish nutrition recommendations emphasizing appropriate energy intake, meal frequency, consumption of fruits, vegetables and berries, quality of dietary fat and carbohydrates, including sugar and fiber intake) and physical exercise (brisk walking a minimum of 30 minutes per day at least five days a week or other types of exercise, e.g. cycling, cross-country skiing, housework such as leafs raking, resistance training).
Behavioral: Lifestyle intervention
Life-style intervention includes 7-9 group sessions (two additional group sessions for participants whose body mass index exceeds 28 kg/m2) on diet (healthy diet according to Nordic and Finnish nutrition recommendations emphasizing appropriate energy intake, meal frequency, consumption of fruits, vegetables and berries, quality of dietary fat and carbohydrates, including sugar and fiber intake) and physical exercise (brisk walking a minimum of 30 minutes per day at least five days a week or other types of exercise, e.g. cycling, cross-country skiing, housework such as leafs raking, resistance training).
No Intervention: Control 1
No intervention in participants with low genetic risk score
No Intervention: Control 2
No intervention in participants with high genetic risk score



Primary Outcome Measures :
  1. Incident diabetes [ Time Frame: 3 years ]
    Incident diabetes is defined by fasting plasma glucose ≥ 7.0 mmol/l or 2-hour glucose in an oral glucose tolerance test ≥ 11.1 mmol/l or HbA1c ≥ 6.5% or drug treatment started for diabetes during a 3-year follow-up.


Secondary Outcome Measures :
  1. The change in glucose area under the curve in an oral glucose tolerance test [ Time Frame: 3 years ]
    The glucose area (mmol/l x min) under the curve in an oral glucose tolerance test is calculated on the basis of glucose measurements (mmol/l) at 0, 30 and 120 min. The change in the glucose area under the curve is the difference between the glucose areas under the curve at randomisation and 3-year visits.

  2. The change in insulin secretion during a 3 year follow-up [ Time Frame: 3 years ]
    Insulin secretion is measured by calculating the glucose area under the curve (mmol/l x min, based on the measurement of glucose in mmol/l at 0 and 30 min) divided by insulin area under the curve (based on the measurement of insulin in pmol/l at 0 and 30 min). The change in insulin secretion is the difference between insulin secretion measured at randomisation and 3-year visits.

  3. The change in insulin sensitivity during a 3 year follow-up [ Time Frame: 3 years ]
    Insulin sensitivity is measured by the Matsuda index (mg/dl, mU/L) based on insulin and glucose measurements at 0, 30 and 120 min. The change in insulin sensitivity is the difference between the Matsuda index at randomisation and at 3-year follow-up visits.


Other Outcome Measures:
  1. Incident cardiovascular disease [ Time Frame: 3 years ]
    Incident cardiovascular disease is defined as incident fatal or non-fatal myocardial infarction or cardiovascular death or incident non-fatal or fatal stroke



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant of the METSIM Study
  • Impaired fasting glucose (IFG) at entry (fasting plasma glucose 5.6-6.9 mmol/l) and with (2-hour glucose 7.8-11.0 mmol/l) or without impaired glucose tolerance (2-hour glucose <7.8 mmol/l) and HbA1c < 6.5%.
  • Age 50-75 years
  • Male
  • Body mass index ≥ 25 kg/m2

Exclusion Criteria:

  • Age < 50 years or > 75 years
  • Body mass index < 25 kg/m2
  • Type 1 or type 2 diabetes or isolated impaired glucose tolerance (2-hour plasma glucose < 5.6 mmol/l and 2-hour plasma glucose 7.8-11.0 mmol/l) or HbA1c ≥ 6.5%
  • Chronic diseases preventing to participate in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709057


Locations
Finland
University of Eastern Finland Recruiting
Kuopio, Finland, 70210
Contact: Markku Laakso, MD,PhD    +358 40 672 3338    markku.laakso@uef.fi   
Sponsors and Collaborators
University of Eastern Finland

Responsible Party: Markku Laakso, Professor, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT02709057     History of Changes
Other Study ID Numbers: T2D-GENÈ
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases