Prevention of Developing Type 2 DiabetesNCT02212665

Life Without Diabetes

A study testing High intense interval training, Increased daily activity detected by the pedometer and Increased daily activity detected by the pedometer+HIIT in people with Prevention of Developing Type 2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Prevention of Developing Type 2 Diabetes
What is being tested?: High intense interval training, Increased daily activity detected by the pedometer and Increased daily activity detected by the pedometer+HIIT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteDenmark
Study dates: Jan 2014to Dec 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Denmark1 site

Center for Diabetes Research, Gentofte Hospital
Hellerup, 2900

Other trials in Denmark

About this study

Read the 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).

Conditions: Prevention of Developing Type 2 Diabetes
Being tested: High intense interval training, Increased daily activity detected by the pedometer, Increased daily activity detected by the pedometer+HIIT, Increased daily activity detected by the pedometer+group intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High intense interval trainingBehavioural
Increased daily activity detected by the pedometerBehavioural
Increased daily activity detected by the pedometer+HIITBehavioural
Increased daily activity detected by the pedometer+group interventionBehavioural

Study groups in NCT02212665
Study group	Role	What they receive
High intense interval training (HIIT)	Experimental	3 x 20 sec, 3 x week Receives: Behavioral: High intense interval training
Increased daily activity detected by the pedometer	Experimental	10.000 steps a day Receives: Behavioral: Increased daily activity detected by the pedometer
Increased daily activity detected by te pedometer+HIIT	Experimental	10.000 steps + 3 x 20 sec, 3 x week Receives: Behavioral: Increased daily activity detected by the pedometer+HIIT
Increased daily activity (pedometer)+group intervention	Experimental	10.000 steps + group intervention Receives: Behavioral: Increased daily activity detected by the pedometer+group intervention
Control group	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: At baseline and after 12 weeks

Secondary outcomes (6)

Changes in oxygen peak oxygen uptake
Assessed from a physical fitness test (VO2peak)
Measured: At baseline and after 12 weeks
Changes in glycaemic control
Measured as fasting plasma glucose, HbA1c
Measured: 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)
Measured: At baseline and after 12 weeks
Changes in body weight (kg)
Measured by Dual-energy X-ray Absorptiometry, DXA
Measured: 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)
Measured: 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.
Measured: At baseline and after 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Dec 2017

First posted8 Aug 2014 (estimated)
Study startJan 2014
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prevention of Developing Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02212665
Sponsor's protocol ID: H-4-2013-079
Status last verified: Jul 2021
First submitted: 6 Aug 2014
Last updated: 9 Jul 2021
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Life Without Diabetes
ClinicalTrials.gov ID: NCT02212665
Acronym / sponsor ID: H-4-2013-079
Conditions: Prevention of Developing Type 2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: University Hospital, Gentofte, CopenhagenUniversity, hospital or other
Study start: Jan 2014
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 8 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
High intense interval training (HIIT)	Experimental	Behavioral: High intense interval training3 x 20 sec, 3 x week
Increased daily activity detected by the pedometer	Experimental	Behavioral: Increased daily activity detected by the pedometer10.000 steps a day
Increased daily activity detected by te pedometer+HIIT	Experimental	Behavioral: Increased daily activity detected by the pedometer+HIIT10.000 steps + 3 x 20 sec, 3 x week
Increased daily activity (pedometer)+group intervention	Experimental	Behavioral: Increased daily activity detected by the pedometer+group intervention10.000 steps + group intervention
Control group	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High intense interval training	Behavioural	High intense interval training (HIIT)
Increased daily activity detected by the pedometer	Behavioural	Increased daily activity detected by the pedometer
Increased daily activity detected by the pedometer+HIIT	Behavioural	Increased daily activity detected by te pedometer+HIIT
Increased daily activity detected by the pedometer+group intervention	Behavioural	Increased daily activity (pedometer)+group intervention

Primary outcome

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

6 secondary outcomes

Changes in oxygen peak oxygen uptake
Time frame: At baseline and after 12 weeks
Changes in glycaemic control
Time frame: 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
Changes in body weight (kg)
Time frame: 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
Patient-reported outcome measure
Time frame: At baseline and after 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in insulin sensitivity (time frame: At baseline and after 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02212665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.