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临床试验/NCT05747118
NCT05747118已完成不适用

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

Steno Diabetes Center Greenland1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
Adherence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Severe heart disease

结局指标

主要结局

Adherence

时间窗: 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.

次要结局

  • Change in HDL cholesterol(Baseline to 12 weeks)
  • Change in BMI(Baseline to 12 weeks)
  • Change in LDL cholesterol(Baseline to 12 weeks)
  • Change in fat mass(Baseline to 12 weeks)
  • Change in muscle mass(Baseline to 12 weeks)
  • Change in quality of life(Baseline to 12 weeks)
  • Change in bone mass(Baseline to 12 weeks)
  • Change in Total cholesterol(Baseline to 12 weeks)
  • Change in triglycerides(Baseline to 12 weeks)
  • Change in blood pressure(Baseline to 12 weeks)
  • Change in HbA1c(Baseline to 12 weeks)

研究者

发起方
Steno Diabetes Center Greenland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maja Hykkelbjerg Nielsen

MSc in Public Health, PhD student

Steno Diabetes Center Greenland

研究点 (1)

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