Life Without Diabetes

NCT ID: NCT02212665

Last Updated: 2021-07-09

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

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

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).

Conditions

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Prevention of Developing Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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High intense interval training (HIIT)

3 x 20 sec, 3 x week

Group Type EXPERIMENTAL

High intense interval training

Intervention Type BEHAVIORAL

Increased daily activity detected by the pedometer

10.000 steps a day

Group Type EXPERIMENTAL

Increased daily activity detected by the pedometer

Intervention Type BEHAVIORAL

Increased daily activity detected by te pedometer+HIIT

10.000 steps + 3 x 20 sec, 3 x week

Group Type EXPERIMENTAL

Increased daily activity detected by the pedometer+HIIT

Intervention Type BEHAVIORAL

Increased daily activity (pedometer)+group intervention

10.000 steps + group intervention

Group Type EXPERIMENTAL

Increased daily activity detected by the pedometer+group intervention

Intervention Type BEHAVIORAL

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High intense interval training

Intervention Type BEHAVIORAL

Increased daily activity detected by the pedometer

Intervention Type BEHAVIORAL

Increased daily activity detected by the pedometer+HIIT

Intervention Type BEHAVIORAL

Increased daily activity detected by the pedometer+group intervention

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Pernille Mensberg

MSc, ph.d-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Diabetes Research, Gentofte Hospital

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-4-2013-079

Identifier Type: -

Identifier Source: org_study_id

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