Life Without Diabetes

July 5, 2021 updated by: Pernille Mensberg, University Hospital, Gentofte, Copenhagen
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Center for Diabetes Research, Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in insulin sensitivity
Time Frame: At baseline and after 12 weeks
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
Time Frame: At baseline and after 12 weeks
Assessed from a physical fitness test (VO2peak)
At baseline and after 12 weeks
Changes in glycaemic control
Time Frame: At baseline and after 12 weeks
Measured as fasting plasma glucose, HbA1c
At baseline and after 12 weeks
Changes in key proteins in glucose and fat metabolism (Skeletal muscle)
Time Frame: At baseline and after 12 weeks
Expression/content of key proteins in skeletal muscle tissure (AU units)
At baseline and after 12 weeks
Changes in body weight (kg)
Time Frame: At baseline and after 12 weeks
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)
Time Frame: At baseline and after 12 weeks
Expression/content of key proteins in adipose tissue (AU units)
At baseline and after 12 weeks
Patient-reported outcome measure
Time Frame: At baseline and after 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 8, 2014

Study Record Updates

Last Update Posted (Actual)

July 9, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2013-079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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