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Completed

NCT Number: NCT05747118

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders MODY Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Steno Diabetes Center Greenland

Nuuk, 3900, Greenland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Severe heart disease

Treatment and study plan

physical training

Behavioral

A 12 week supervised training intervention with 1 hour physical training two times a week.

Primary outcomes

  1. Adherence

    Time frame: 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 outcomes

  1. Change in quality of life

    Time frame: 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.

  2. Change in BMI

    Time frame: Baseline to 12 weeks

    BMI is measured using height and weight.

  3. Change in fat mass

    Time frame: Baseline to 12 weeks

    Fat mass is measured using tanita body composition analyzer.

  4. Change in muscle mass

    Time frame: Baseline to 12 weeks

    Muscle mass is measured using tanita body composition analyzer.

  5. Change in bone mass

    Time frame: Baseline to 12 weeks

    Bone mass is measured using tanita body composition analyzer.

  6. Change in blood pressure

    Time frame: Baseline to 12 weeks

    Blood pressure is measured with a blood pressure monitor.

  7. Change in HbA1c

    Time frame: Baseline to 12 weeks

    HbA1c is measured with a blood sample.

  8. Change in HDL cholesterol

    Time frame: Baseline to 12 weeks

    HDL cholesterol is measured with a blood sample.

  9. Change in LDL cholesterol

    Time frame: Baseline to 12 weeks

    LDL cholesterol is measured with a blood sample.

  10. Change in Total cholesterol

    Time frame: Baseline to 12 weeks

    Total cholesterol is measured with a blood sample.

  11. Change in triglycerides

    Time frame: Baseline to 12 weeks

    Triglycerides is measured with a blood sample.

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Greenland

Other

Collaborators

  • University of Southern Denmark

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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