Life Without Diabetes

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Prevention of Developing Type 2 Diabetes

Treatments: Behavioral: Increased daily activity detected by the pedometer+HIIT; Behavioral: Increased daily activity detected by the pedometer+group intervention; Behavioral: Increased daily activity detected by the pedometer; Behavioral: High intense interval training

Study type: Interventional

Funder types: Other

Identifiers

NCT02212665

H-4-2013-079

Details and patient eligibility

About

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

Full description

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).

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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59 participants in 5 patient groups

High intense interval training (HIIT)

Experimental group

Description:

3 x 20 sec, 3 x week

Treatment:

Behavioral: High intense interval training

Increased daily activity detected by the pedometer

Experimental group

Description:

10.000 steps a day

Treatment:

Behavioral: Increased daily activity detected by the pedometer

Increased daily activity detected by te pedometer+HIIT

Experimental group

Description:

10.000 steps + 3 x 20 sec, 3 x week

Treatment:

Behavioral: Increased daily activity detected by the pedometer+HIIT

Increased daily activity (pedometer)+group intervention

Experimental group

Description:

10.000 steps + group intervention

Treatment:

Behavioral: Increased daily activity detected by the pedometer+group intervention

Control group

No Intervention group