The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tina Vilsboll, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01455441
First received: October 19, 2011
Last updated: December 13, 2013
Last verified: December 2013
  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 Study Completion Date: June 2014
Primary Completion Date: June 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

Locations
Denmark
Department of Internal Medicine, Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Tina Vilsboll
  More Information

No publications provided

Responsible Party: Tina Vilsboll, Professor dr.med, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01455441     History of Changes
Other Study ID Numbers: 60 - TrainIncretin
Study First Received: October 19, 2011
Last Updated: December 13, 2013
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 April 22, 2014