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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05747118
Enrollment
18
Registered
2023-02-28
Start date
2022-08-15
Completion date
2022-12-31
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MODY, Type 2 Diabetes

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.

Interventions

BEHAVIORALPhysical training

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

Sponsors

University of Southern Denmark
CollaboratorOTHER
Steno Diabetes Center Greenland
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* Severe heart disease

Design outcomes

Primary

MeasureTime frameDescription
AdherenceBaseline to 12 weeksAdherence 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

MeasureTime frameDescription
Change in BMIBaseline to 12 weeksBMI is measured using height and weight.
Change in fat massBaseline to 12 weeksFat mass is measured using tanita body composition analyzer.
Change in muscle massBaseline to 12 weeksMuscle mass is measured using tanita body composition analyzer.
Change in bone massBaseline to 12 weeksBone mass is measured using tanita body composition analyzer.
Change in blood pressureBaseline to 12 weeksBlood pressure is measured with a blood pressure monitor.
Change in quality of lifeBaseline to 12 weeksQuality 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 HDL cholesterolBaseline to 12 weeksHDL cholesterol is measured with a blood sample.
Change in LDL cholesterolBaseline to 12 weeksLDL cholesterol is measured with a blood sample.
Change in Total cholesterolBaseline to 12 weeksTotal cholesterol is measured with a blood sample.
Change in triglyceridesBaseline to 12 weeksTriglycerides is measured with a blood sample.
Change in HbA1cBaseline to 12 weeksHbA1c is measured with a blood sample.

Countries

Greenland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026