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Life Without Diabetes

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ClinicalTrials.gov Identifier: NCT02212665
Recruitment Status : Unknown
Verified May 2017 by Pernille Mensberg, University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : August 8, 2014
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Pernille Mensberg, University Hospital, Gentofte, Copenhagen

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Prevention of Developing Type 2 Diabetes 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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Life Without Diabetes
Study Start Date : January 2014
Estimated Primary Completion Date : December 30, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
No Intervention: Control group



Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 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


Secondary Outcome Measures :
  1. Changes in body composition and maximal oxygen uptake [ Time Frame: 12 weeks ]
    Changes in body composition assessed by DXA-scan and maximal oxygen uptake physical fitness test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212665


Locations
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Denmark
Center for Diabetes Research, Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen

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Responsible Party: Pernille Mensberg, MSc, ph.d-student, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT02212665     History of Changes
Other Study ID Numbers: H-4-2013-079
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases