Life Without Diabetes

Study Overview
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Brief Summary
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The aim of the study 'Live - without diabetes' is to investigate the effects of increased physical activity on a daily basis with or without (high intense interval training) HIIT (short and intense: 3 minutes per week) during 12 weeks in risk individuals with pre-diabetes

Detailed Description
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A total of 125 individuals with pre-diabetes will be included and randomized into four different groups (N=25, each group): 1) Increased daily activity detected by the pedometer, 2) increased daily activity detected by the pedometer + HIIT, 3) HIIT, and 4) increased daily activity detected by the pedometer + group intervention 5) a control group (maintain unchanged activity and life-style during the duration of the study).

Official Title
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Life Without Diabetes

Conditions
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Prevention of Developing Type 2 Diabetes

Intervention / Treatment
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* Behavioral: High intense interval training
* Behavioral: Increased daily activity detected by the pedometer
* Behavioral: Increased daily activity detected by the pedometer+HIIT
* Behavioral: Increased daily activity detected by the pedometer+group intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) > 25 kg/m2 Prediabetes: 6.1 % ≤ glycated hemoglobin A1c (HbA1c) ≤ 6.4 % and / or increased fasting plasma glucose (FPG): 6.1 mM ≤ FPG ≤ 6.9 mM and / or abnormal glucose tolerance (7.8 mM ≤ 2 hour plasma glucose (PG) ≤ 11.0 mmol) Weekly training status <150 minutes Exclusion Criteria: BMI <25 kg/m2 Diabetes Pregnancy and breastfeeding Treatment with medicine, there influence glucose metabolism Decreased liver function (liver transaminases > 3 times of limit of normal)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intense interval training (HIIT)<br>3 x 20 sec, 3 x week | Behavioral: High intense interval training<br> <br> |
| Experimental: Increased daily activity detected by the pedometer<br>10.000 steps a day | Behavioral: Increased daily activity detected by the pedometer<br> <br> |
| Experimental: Increased daily activity detected by te pedometer+HIIT<br>10.000 steps + 3 x 20 sec, 3 x week | Behavioral: Increased daily activity detected by the pedometer+HIIT<br> <br> |
| Experimental: Increased daily activity (pedometer)+group intervention<br>10.000 steps + group intervention | Behavioral: Increased daily activity detected by the pedometer+group intervention<br> <br> |
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in insulin sensitivity | The primary endpoint is insulin sensitivity, and it will be assessed by changes in the area under the curve from baseline to end-of-study assessed by the Cederholm Index and Matsuda Index | At baseline and after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in oxygen peak oxygen uptake | Assessed from a physical fitness test (VO2peak) | At baseline and after 12 weeks | 
| Changes in glycaemic control | Measured as fasting plasma glucose, HbA1c | At baseline and after 12 weeks | 
| Changes in key proteins in glucose and fat metabolism (Skeletal muscle) | Expression/content of key proteins in skeletal muscle tissure (AU units) | At baseline and after 12 weeks | 
| Changes in body weight (kg) | Measured by Dual-energy X-ray Absorptiometry, DXA | At baseline and after 12 weeks | 
| Changes in key proteins in glucose and fat metabolism (Adipose fat tissure) | Expression/content of key proteins in adipose tissue (AU units) | At baseline and after 12 weeks | 
| Patient-reported outcome measure | Health related quality of life measured from Short Form 36 (SF36). Where scores are presented as norm-based scores (0-100) with higher scores indicating better perceived health status. | At baseline and after 12 weeks |