The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes
This study is currently recruiting participants.
Verified September 2011 by University Hospital, Gentofte, Copenhagen
Sponsor:
University Hospital, Gentofte, Copenhagen
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01455441
First received: October 19, 2011
Last updated: June 12, 2012
Last verified: September 2011
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Purpose
The objective of this study is to investigate the effects of physical training in patients with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®) in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.
Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients when training is combined with liraglutide (Victoza®) treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Other: Training and liraglutide Other: Training and placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes? |
Resource links provided by NLM:
Further study details as provided by University Hospital, Gentofte, Copenhagen:
Primary Outcome Measures:
- HbA1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Change in HbA1c from baseline to 16 weeks. Glycated haemoglobin (HbA1c) is a form of haemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time (12 weeks).
Secondary Outcome Measures:
- Maximal oxygen uptake (VO2peak) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Changes in VO2peak from baseline to 16 weeks
- Body weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Changes in body weight from baseline to 16 weeks evaluated by a full body DEXA scan
- Blood pressure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Changes in blood pressure from baseline to 16 weeks
- Glycaemic control [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Changes in overall glycaemic control parameters, insulin sensitivity and beta cell function evaluated by The Homeostasis Model Assessment (HOMA) and incretin hormones response
- Meal test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The changes in the postprandial response of incretin hormones, insulin and glucose, glucagon and the microvascular blood flow will be evaluated. Changes in blood leves of triglycerides and cholesterol.
- Myocardial echocardiography [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Training and liraglutide
Treatment with both training and liraglutide for 16 weeks
|
Other: Training and liraglutide |
|
Placebo Comparator: Training and placebo
Treatment wiht both training and placebo for 16 weeks
|
Other: Training and placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed oral and written consent
- 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:
- Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455441
Contacts
| Contact: Tina Vilsbøll, dr. med | t.vilsboll@dadlnet.dk |
Locations
| Denmark | |
| Department of Internal Medicine, Gentofte Hospital | Recruiting |
| Hellerup, Denmark, 2900 | |
| Contact: Tina Vilsbøll, dr. med t.vilsboll@dadlnet.dk | |
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01455441 History of Changes |
| Other Study ID Numbers: | 60 - TrainIncretin |
| Study First Received: | October 19, 2011 |
| Last Updated: | June 12, 2012 |
| Health Authority: | Denmark: Ethics Committee Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency |
Keywords provided by University Hospital, Gentofte, Copenhagen:
|
GLP-1 Training Exercise Type 2 Diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013