Influence of Moderate Exercise on Blood Glucose in Type 2 Diabetics and Healthy Controls (DIEGO)

This study has been completed.
Sponsor:
Collaborators:
Department of Biomedical Sciences
XLab, Center of Healthy Aging
Information provided by (Responsible Party):
Merethe Hansen, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01765894
First received: November 30, 2012
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

Project description

Research project title:

Influence of moderate exercise on blood glucose in type 2 diabetics and healthy controls.

Project description and objective

Obesity is so widespread in Denmark that 47% of the population is classed as overweight (BMI>=25) and around 13% of the population is classed as obese (BMI>=30).

The strong correlation between obesity and type 2 diabetes (at least 2/3 of type 2 diabetics are overweight) has led to many studies which look at different forms of exercise for this group, because weight loss may improve the diabetes and even defer the onset of the disorder and in doing so lower complications and increase long term survival.

For people who do not have type 2 diabetes, the work-induced increased sympathetic activity will lead to suppressed insulin secretion and increased glucagon secretion. This increases the endogenous glucose production from the liver and thus maintains a normal concentration of blood sugar in a physical training situation where the demand for glucose has increased.

The theory behind the project is that the mechanisms that help to increase glucose production in the liver during physical activity are weaker in type 2 diabetics, which can cause hypoglycaemia during and after physical exercise. In other words, we want to study the liver's sensitivity to stimulus from physical work by patients with type 2 diabetes and in relevant healthy control subjects.

Previous studies have indicated that this type of mechanism is not intact in type 2 diabetics; because the level of insulin does not fall as expected during or after physical training. However, there are no existing studies that measure the liver's glucose secretion using stable isotopes during prolonged moderate physical work. Measuring this will help to clarify our understanding of glucose homeostasis in type 2 diabetics.

This study is very relevant, because it may be expected that the preferred form of physical exercise of an overweight type 2 diabetic can be of moderate intensity and previous studies also show that this form of physical exercise delivers health gains in terms of an improvement in insulin sensitivity and a reduction in the level of insulin.

The objective of this study is to determine if the level of blood glucose stays constant before, during and after physical training and to examine the liver's ability to secret glucose accordingly.


Condition Intervention
Type 2 Diabetes and Exercise
Other: 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Influence of Moderate Exercise on Blood Glucose in Type 2 Diabetics and Healthy Controls.

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Glucose homeostasis in controls, type 2 diabetics without medication and type 2 diabetics in metformin treatment. [ Time Frame: Observational study. Glucose homeostasis is tested one day only (in our Lab). Samples are taken 2,5 hours before, during and untill 1 hour after 45 minutes of exercise. Samples are taken every 5 minutes. ] [ Designated as safety issue: No ]

    Glucose, hormones, substrates, metabolites and glucose-isotopes as mentioned in the protocol.

    These end points will be measured on test day 2 only. Hormones and metabolites will be measured as AUC and total concentrations.



Secondary Outcome Measures:
  • MAP during moderate exercise [ Time Frame: 45 min of moderate exercise (test day 2). ] [ Designated as safety issue: No ]
    MAP is continuously measured during exercise for 45 mins. (At 60% heart rate reserve)

  • vo2max [ Time Frame: one measurement each subject (test day 1) ] [ Designated as safety issue: No ]
    Is measured in all subjects prior to test day 2

  • DXA-values [ Time Frame: one measurement each subject (test day 1) ] [ Designated as safety issue: No ]
    DXA (fat%, lean body mass, BMD)is measured prior to test day 2

  • IL-6 and incretins [ Time Frame: Observational study. Each test subject is tested for IL-6 and incretins one day only (in our Lab), where blood samples are taken continously during the test day every 5 minutes before, during and after exercise (test day 2). ] [ Designated as safety issue: No ]
    Effect of exercise on IL-6 and incretins. Described as AUC and total concentrations.


Biospecimen Retention:   Samples With DNA

whole blood and plasma


Enrollment: 24
Study Start Date: October 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Normal glucose tolerance subjects
Healthy controls. If any medication then paused 3 days prior to test days. BMI: 20-35. VO2max: 20-50. Age: 30-60 years All subjects perform same tests. - See protocol for description.
Other: 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.
Other Name: exercise performed at 60% of heart rate reserve.
DM2

Type 2 diabetics in diet treatment or type 2 diabetics who have paused their oral medication for 3 whole days.

Insulin treatment is an exclusion criteria. If any other medication then paused 3 days prior to test days.

BMI: 20-35. VO2max: 20-50. Age: 30-60 years All subjects perform same tests. - See protocol for description.

Other: 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.
Other Name: exercise performed at 60% of heart rate reserve.
DM2 + Metformin

Type 2 diabetics in metformin treatment. Insulin treatment is an exclusion criteria. If any other medication (besides from metformin) then paused 3 days prior to test days.

BMI: 20-35. VO2max: 20-50. Age: 30-60 years All subjects perform same tests. - See protocol for description

Other: 45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.
Other Name: exercise performed at 60% of heart rate reserve.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • 10 type 2 Diabetics without medication
  • 10 type 2 Diabetics on Metformin treatment
  • 10 matched healthy controls
Criteria

Inclusion Criteria:

  • Age between 30 and 60 years old
  • Maximum oxygen consumption between 20 and 50 ml/kg/minute
  • BMI between 25 and 35 kg/m2
  • Normal ECG
  • Must have a stable weight throughout the last three months and have a normal balanced diet
  • Can cycle for 45 minutes

Exclusion Criteria:

  • For patients with type 2 diabetes: insulin treatment
  • ECG that indicates cardiovascular disease
  • Illness or medicine that may affect the results
  • On-going weight loss diet
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01765894

Locations
Denmark
XLab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Department of Biomedical Sciences
XLab, Center of Healthy Aging
Investigators
Principal Investigator: Flemming Dela, professor University of Copenhagen
  More Information

Additional Information:
No publications provided

Responsible Party: Merethe Hansen, PhD student Merethe Hansen, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01765894     History of Changes
Other Study ID Numbers: H-1-2012-074
Study First Received: November 30, 2012
Last Updated: February 21, 2014
Health Authority: Denmark: Research Ethics Committee of the Capital Region of Denmark

Keywords provided by University of Copenhagen:
glucose homeostasis
endogenous glucose production
moderate exercise
type 2 diabetes
metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014