Type 2 DiabetesT2D-GENENCT02709057
Lifestyle Intervention in Individuals With Low or High Genetic Risk for Type 2 Diabetes
A study testing Lifestyle intervention in people with Type 2 Diabetes, run by University of Eastern Finland at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
AIM: 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 type 2 diabetes (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.
STUDY GROUPS. A total of 600 participants will be selected from the METabolic Syndrome In Men (METSIM) study. They are divided into two groups: a) high genetic risk for T2DM on the basis of the genetic risk score (N=300), and b) low genetic risk score for T2DM on the basis of the genetic risk score (N=300). For both of these groups a corresponding control group (N=300) will be selected.
PROTOCOL. 1) The first visit at entry (visit 1) for both intervention and control groups: an interview about physical activity at work and leisure time, smoking, alcohol use, education, occupation, diet, history of medication; clinical measurements: blood pressure, body weight, height, bioimpedance; laboratory measurements including an oral glucose tolerance test, fasting measurements (HbA1c, total cholesterol, HDL cholesterol, total triglycerides, ALT, GAD antibodies); 2) Group sessions (about 15 participants in each) 1-7 described below for the intervention group but not for the control group, 3) A 6 month and 24 month visits (identical to visit 1) for the intervention group but not for the control group; 4) A 3-year visit for both intervention and control groups (identical to visit 1).
Detailed protocol for the intervention group: Dietary guidance in the intervention group is based on the Nordic and Finnish nutrition recommendations and they emphasize appropriate energy intake, meal frequency, consumption of fruits vegetables and berriers, quality of dieatry fat and cardohydrates, including sugar and fiber intake. During the intervention the goals for nutrient and food intake (healthy diet) are: Vegetables, fruits and berries >= 500 g/day, carbohydrates 45-60 E%, sucrose < 10 E%, fiber >=35 g/day, fat 25-40 E%, saturated fat < 10 E%, unsaturated fat >= 2/3 of total fat E%, monosaturated fat 10-20 E%, polysaturated fat 5-10 E%, n-3 fatty acids >= 1E%. The goal for physical activity is brisk walking a minimum of 30 min/day at least five days a week. Walking could be replaced by other types of exercise (e.g. cycling, crioss-country skiing, resistance training, and housework such as leaft raking);
The first year of the intervention will be the most active and includes 4-6 group sessions depending on participants' needs. Group sessions for the intervention group:
Session1 (month 1): Motivation and a 4-day food record and personal feedback from food records to participants.
Sessions 2 and 3 (month 1-2): Healthy dietary pattern and physical activity (see above) Sessions 4 and 5 (month 2-3): Dietary advice for weight loss for the participants with BMI > 28 kg/m2.
6 months visit: 4-day food record and personal feedback from food records to participants.
Session 6: month 12: 4-day food record and personal feedback from food records to participants. Advice for healthy diet and physical activity. Adidtionally a measurement of HbA1c; Session 7 (month 24): 4-day food record and personal feedback from food records to participants. Advice for healthy dietary pattern and physical activity and performance of an oral glucose tolerance test and HbA1c.
Final visit at 36 months: An oral glucose toletance test, HbA1c, and food frequency questionnaire for both intervention and control groups.
Thoughout the study the subjects in the intervention groups will be regularly contacted by the researchers via the website in order to ensure that the subjects stay active regarding the intervention. The web portal also enables the distribution of material and makes virtual discussion possible between the participants and clinical nutritionists. Printed material and discussions by phone will be provided to the participants who do not have access to the internet. In order to help the participants recognize their needs for changes in the diet, available tests (e.g. fiber test, sugar test, fat quality test) provided by the Finnish Heart Association and the Finnish Diabetes Association will be used.
- Conditions
- Type 2 Diabetes
- Being tested
- Lifestyle intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
The change in glucose area under the curve in an oral glucose tolerance test
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.
Measured: 3 years
The change in insulin secretion during a 3 year follow-up
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.
Measured: 3 years
The change in insulin sensitivity during a 3 year follow-up
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markku Laakso, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709057
- Sponsor's protocol ID
- T2D-GENÈ
- Acronym
- T2D-GENE
- Status last verified
- Feb 2021
- First submitted
- 6 Mar 2016
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 40961511Schwab 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.
PubMed 34650392
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02709057
- Acronym / sponsor ID
- T2D-GENE / T2D-GENÈ
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AIM: 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 type 2 diabetes (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.
STUDY GROUPS. A total of 600 participants will be selected from the METabolic Syndrome In Men (METSIM) study. They are divided into two groups: a) high genetic risk for T2DM on the basis of the genetic risk score (N=300), and b) low genetic risk score for T2DM on the basis of the genetic risk score (N=300). For both of these groups a corresponding control group (N=300) will be selected.
PROTOCOL. 1) The first visit at entry (visit 1) for both intervention and control groups: an interview about physical activity at work and leisure time, smoking, alcohol use, education, occupation, diet, history of medication; clinical measurements: blood pressure, body weight, height, bioimpedance; laboratory measurements including an oral glucose tolerance test, fasting measurements (HbA1c, total cholesterol, HDL cholesterol, total triglycerides, ALT, GAD antibodies); 2) Group sessions (about 15 participants in each) 1-7 described below for the intervention group but not for the control group, 3) A 6 month and 24 month visits (identical to visit 1) for the intervention group but not for the control group; 4) A 3-year visit for both intervention and control groups (identical to visit 1).
Detailed protocol for the intervention group: Dietary guidance in the intervention group is based on the Nordic and Finnish nutrition recommendations and they emphasize appropriate energy intake, meal frequency, consumption of fruits vegetables and berriers, quality of dieatry fat and cardohydrates, including sugar and fiber intake. During the intervention the goals for nutrient and food intake (healthy diet) are: Vegetables, fruits and berries >= 500 g/day, carbohydrates 45-60 E%, sucrose < 10 E%, fiber >=35 g/day, fat 25-40 E%, saturated fat < 10 E%, unsaturated fat >= 2/3 of total fat E%, monosaturated fat 10-20 E%, polysaturated fat 5-10 E%, n-3 fatty acids >= 1E%. The goal for physical activity is brisk walking a minimum of 30 min/day at least five days a week. Walking could be replaced by other types of exercise (e.g. cycling, crioss-country skiing, resistance training, and housework such as leaft raking);
The first year of the intervention will be the most active and includes 4-6 group sessions depending on participants' needs. Group sessions for the intervention group:
Session1 (month 1): Motivation and a 4-day food record and personal feedback from food records to participants.
Sessions 2 and 3 (month 1-2): Healthy dietary pattern and physical activity (see above) Sessions 4 and 5 (month 2-3): Dietary advice for weight loss for the participants with BMI > 28 kg/m2.
6 months visit: 4-day food record and personal feedback from food records to participants.
Session 6: month 12: 4-day food record and personal feedback from food records to participants. Advice for healthy diet and physical activity. Adidtionally a measurement of HbA1c; Session 7 (month 24): 4-day food record and personal feedback from food records to participants. Advice for healthy dietary pattern and physical activity and performance of an oral glucose tolerance test and HbA1c.
Final visit at 36 months: An oral glucose toletance test, HbA1c, and food frequency questionnaire for both intervention and control groups.
Thoughout the study the subjects in the intervention groups will be regularly contacted by the researchers via the website in order to ensure that the subjects stay active regarding the intervention. The web portal also enables the distribution of material and makes virtual discussion possible between the participants and clinical nutritionists. Printed material and discussions by phone will be provided to the participants who do not have access to the internet. In order to help the participants recognize their needs for changes in the diet, available tests (e.g. fiber test, sugar test, fat quality test) provided by the Finnish Heart Association and the Finnish Diabetes Association will be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Life-style intervention 1 | Active comparator | Behavioral: Lifestyle interventionLife-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). |
| Life-style intervention 2 | Active comparator | Behavioral: Lifestyle interventionLife-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). |
| 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 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionLife-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). | Behavioural | Life-style intervention 1, Life-style intervention 2 |
Primary outcome
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.
3 secondary outcomes
The change in glucose area under the curve in an oral glucose tolerance test
Time frame: 3 years
The change in insulin secretion during a 3 year follow-up
Time frame: 3 years
The change in insulin sensitivity during a 3 year follow-up
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Derived from this study: PubMed 40961511Tolonen 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.
- Derived from this study: PubMed 34650392Schwab 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Type 2 Diabetes, run by University of Eastern Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident diabetes (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02709057, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.