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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014