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

NCT ID: NCT05747118

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-15

Study Completion Date

2022-12-31

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:

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

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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.

Conditions

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Type 2 Diabetes MODY

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Intervention

People with type 2 diabetes or MODY in the training group

Physical training

Intervention Type BEHAVIORAL

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

Control

People with type 2 diabetes or MODY in the control group

No interventions assigned to this group

Interventions

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Physical training

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Steno Diabetes Center Greenland

OTHER

Sponsor Role lead

Responsible Party

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Maja Hykkelbjerg Nielsen

MSc in Public Health, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Steno Diabetes Center Greenland

Nuuk, , Greenland

Site Status

Countries

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Greenland

Other Identifiers

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2022-21

Identifier Type: -

Identifier Source: org_study_id

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