Lifestyle Intervention in Individuals With Low or High Genetic Risk for Type 2 Diabetes

NCT02709057 | Unknown

• 1 other identifier: T2D-GENÈ
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Incident diabetes

  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.

  3 years

Secondary Outcomes (3)

• The change in glucose area under the curve in an oral glucose tolerance test

  3 years

• The change in insulin secretion during a 3 year follow-up

  3 years

• The change in insulin sensitivity during a 3 year follow-up

  3 years

Other Outcomes (1)

• Incident cardiovascular disease

  3 years

Study Arms (4)

Life-style intervention 1

ACTIVE COMPARATOR

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 2

ACTIVE COMPARATOR

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

Control 1

NO INTERVENTION

No intervention in participants with low genetic risk score

Control 2

NO INTERVENTION

No intervention in participants with high genetic risk score

Interventions

Lifestyle intervention BEHAVIORAL

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).

Life-style intervention 1; Life-style intervention 2

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Eastern Finland: lead

Study Sites (1)

University of Eastern Finland

Kuopio, 70210, Finland

Location

Related Publications (2)

• Tolonen UK, Lankinen MA, Laakso M, Schwab US. Association of dietary fibre with type 2 diabetes risk is modified by transcription factor 7 like 2 genotype in men with impaired fasting glucose: The T2D-GENE study. Clin Nutr. 2025 Oct;53:262-269. doi: 10.1016/j.clnu.2025.09.002. Epub 2025 Sep 9.

  PMID: 40961511 DERIVED

• Schwab U, Lankinen M, Laakso M. Effect of lifestyle intervention on the risk of incident diabetes in individuals with impaired fasting glucose and low or high genetic risk for the development of type 2 diabetes in men: a T2D-GENE trial. Food Nutr Res. 2021 Sep 23;65. doi: 10.29219/fnr.v65.7721. eCollection 2021.

  PMID: 34650392 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: March 15, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)