The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes
NCT ID: NCT01455441
Last Updated: 2015-05-29
Study Results
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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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2011-10-31
2014-06-30
Brief Summary
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Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients when training is combined with liraglutide (Victoza®) treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Training and liraglutide
Treatment with both training and liraglutide for 16 weeks
Training and liraglutide
Training and placebo
Treatment wiht both training and placebo for 16 weeks
Training and placebo
Interventions
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Training and liraglutide
Training and placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with type 2 diabetes according to the criteria of the WHO
* HbA1C: 7-11% (doing treatment with diet and/or metformin)
* Age \>18 years
* BMI \>25 kg/m2 \<40 kg/m2
* Negative islet cell antibodies (ICA) and glutamate decarboxylase 65 (GAD- 65) autoantibodies
Exclusion Criteria
* Subjects treated with sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, insulin or glitazones
* Ongoing abuse of alcohol or narcotics
* Impaired hepatic function (liver transaminases \>2 times upper normal limit)
* Impaired renal function (se-creatinine \>150μM and/or albuminuria)
* Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
* Uncontrolled hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>100 mmHg)
* Anaemia
* Any condition that the investigators feels would interfere with trial participation
* Receiving any investigational drug within the last 3 months
18 Years
80 Years
ALL
No
Sponsors
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Tina Vilsboll
OTHER
Responsible Party
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Tina Vilsboll
Professor dr.med
Locations
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Department of Internal Medicine, Gentofte Hospital
Hellerup, , Denmark
Countries
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Other Identifiers
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60 - TrainIncretin
Identifier Type: -
Identifier Source: org_study_id
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