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Completed

NCT Number: NCT01455441

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

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.

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Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Internal Medicine, Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training and liraglutide

Other

Training and placebo

Other

Primary outcomes

  1. HbA1c

    Time frame: 16 weeks

    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 outcomes

  1. Maximal oxygen uptake (VO2peak)

    Time frame: 16 weeks

    Changes in VO2peak from baseline to 16 weeks

  2. Body weight

    Time frame: 16 weeks

    Changes in body weight from baseline to 16 weeks evaluated by a full body DEXA scan

  3. Blood pressure

    Time frame: 16 weeks

    Changes in blood pressure from baseline to 16 weeks

  4. Glycaemic control

    Time frame: 16 weeks

    Changes in overall glycaemic control parameters, insulin sensitivity and beta cell function evaluated by The Homeostasis Model Assessment (HOMA) and incretin hormones response

  5. Meal test

    Time frame: 16 weeks

    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.

  6. Myocardial echocardiography

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Tina Vilsboll

Other

Registry information

Official study title

Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Oct 20, 2011
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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