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

Completed

• Conditions: Type 2 Diabetes; MODY
• Interventions: Behavioral: Physical training

• Registration Number: NCT05747118
• Lead Sponsor: Steno Diabetes Center Greenland

Brief Summary

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:

1. To investigate the feasibility of supervised training for people with T2DM or MODY in a clinical context in Greenland.

2. To investigate evidence of the effect of combined aerobic and strength training on cardiometabolic risk factors and mental well-being.

3. To investigate the signs of efficacy and different interactions with the type of disease.

Detailed Description

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.

Study Timeline

• Study Start: 2022-08-15
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Type 2 diabetes or MODY
• Living in the capital in Greenland, Nuuk

Exclusion Criteria

• Severe heart disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	Physical training	People with type 2 diabetes or MODY in the training group

Primary Outcome Measures

Name	Time	Method
Adherence	Baseline to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure	Baseline to 12 weeks	Blood pressure is measured with a blood pressure monitor.
Change in HbA1c	Baseline to 12 weeks	HbA1c is measured with a blood sample.
Change in BMI	Baseline to 12 weeks	BMI is measured using height and weight.
Change in LDL cholesterol	Baseline to 12 weeks	LDL cholesterol is measured with a blood sample.
Change in fat mass	Baseline to 12 weeks	Fat mass is measured using tanita body composition analyzer.
Change in muscle mass	Baseline to 12 weeks	Muscle mass is measured using tanita body composition analyzer.
Change in quality of life	Baseline to 12 weeks	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.
Change in Total cholesterol	Baseline to 12 weeks	Total cholesterol is measured with a blood sample.
Change in triglycerides	Baseline to 12 weeks	Triglycerides is measured with a blood sample.
Change in bone mass	Baseline to 12 weeks	Bone mass is measured using tanita body composition analyzer.
Change in HDL cholesterol	Baseline to 12 weeks	HDL cholesterol is measured with a blood sample.

Trial Locations

Locations (1)

Steno Diabetes Center Greenland; 🇬🇱 Nuuk, Greenland