A Feasibility Study of a 12 Week Training Intervention With Patients With Type 2 Diabetes and MODY in Greenland

Study Overview
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Brief Summary
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The goal of this study is to investigate to what extent a 12-week training course for people with type 2 diabetes mellitus (T2DM) or MODY can be conducted in a clinical context with clinically relevant improvements in cardiometabolic risk factors and quality of life? The main questions it aims to answer are: To investigate the feasibility of supervised training for people with T2DM or MODY in a clinical context in Greenland. To investigate evidence of the effect of combined aerobic and strength training on cardiometabolic risk factors and mental well-being. To investigate the signs of efficacy and different interactions with the type of disease.

Detailed Description
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Globally, type 2 diabetes mellitus (T2DM) is a major public health issue. This is also the fact in Greenland, the biggest island in the world. Twice as many Greenlanders as Danes have diabetes, and this is due to both lifestyle and genes. It is estimated that 7% of T2DM patients in Greenland have Maturity Onset Diabetes of the Young (MODY), which is hereditary and rare elsewhere. Exercise improves blood sugar control in T2DM, reduces cardiovascular risk factors such as hypertension and dyslipidemia, contributes to weight loss and improves fitness and well-being. Less is known of how people with MODY responds to exercise. Today, the Greenlandic health care system only offers supervised physical training to people with osteoarthritis in two towns in Greenland, but in the future, they would like to offer supervised physical training to people with other conditions too. Relevance: As mentioned above, this study aims to evaluate the feasibility of a 12-week supervised physical training intervention for people with T2DM or MODY and to investigate signs of efficacy and different interactions with the type of disease.

Official Title
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A Feasibility Study of a 12 Week Training Intervention With Patients With Type 2 Diabetes and MODY in Greenland

Conditions
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Type 2 Diabetes, MODY

Intervention / Treatment
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* Behavioral: Physical training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes or MODY Living in the capital in Greenland, Nuuk Exclusion Criteria: Severe heart disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>People with type 2 diabetes or MODY in the training group | Behavioral: Physical training<br>* A 12 week supervised training intervention with 1 hour physical training two times a week.<br>|
| Control<br>People with type 2 diabetes or MODY in the control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Adherence is in this study the proportion of completed training sessions (n=0-24 training sessions). The number of completed training sessions was registered by the physiotherapists. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | Quality of life is estimated using 12-Item Short Form Survey (SF-12). In the short form SF-12, physical (SF12-PCS) and mental (SF12-MCS) component summary scores are calculated as sub-dimensions. The total score of the physical and mental component summary of the scale varies between 0-100. An increase in the score indicates well-being, and a decrease indicates a state of disability. | Baseline to 12 weeks | 
| Change in BMI | BMI is measured using height and weight. | Baseline to 12 weeks | 
| Change in fat mass | Fat mass is measured using tanita body composition analyzer. | Baseline to 12 weeks | 
| Change in muscle mass | Muscle mass is measured using tanita body composition analyzer. | Baseline to 12 weeks | 
| Change in bone mass | Bone mass is measured using tanita body composition analyzer. | Baseline to 12 weeks | 
| Change in blood pressure | Blood pressure is measured with a blood pressure monitor. | Baseline to 12 weeks | 
| Change in HbA1c | HbA1c is measured with a blood sample. | Baseline to 12 weeks | 
| Change in HDL cholesterol | HDL cholesterol is measured with a blood sample. | Baseline to 12 weeks | 
| Change in LDL cholesterol | LDL cholesterol is measured with a blood sample. | Baseline to 12 weeks | 
| Change in Total cholesterol | Total cholesterol is measured with a blood sample. | Baseline to 12 weeks | 
| Change in triglycerides | Triglycerides is measured with a blood sample. | Baseline to 12 weeks |