Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Pregnant Women With and Without Gestational Diabetes Mellitus (GDMakutt)

This study is currently recruiting participants.
Verified April 2014 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01961401
First received: October 9, 2013
Last updated: April 16, 2014
Last verified: April 2014

October 9, 2013
April 16, 2014
January 2013
January 2015   (final data collection date for primary outcome measure)
insulin sensitivity [ Time Frame: 1 day ] [ Designated as safety issue: No ]
insulin sensitivity index, as described by Matsuda and DeFronzo. This calculation uses the fasting plasma glucose and plasma insulin, and the average plasma glucose and insulin values over the 30, 60, 90, and 120 minutes after an oral glucose tolerance test (OGTT), and is calculated as:. 10 000/√[fasting glucose x fasting insulin) x (mean glucose during OGTT x mean insulin during OGTT)]. We will use a carbohydrate rich meal instead of a classic oral glucose tolerance test with glucose in water.
Same as current
Complete list of historical versions of study NCT01961401 on ClinicalTrials.gov Archive Site
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Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Pregnant Women With and Without Gestational Diabetes Mellitus
Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Pregnant Women With and Without Gestational Diabetes Mellitus

Exercise training is recognized as effective in preventing and treating many chronic metabolic disorders (1), and long-term exercise programmes have similar effects on glucose control as long-term drug or insulin therapy in type 2 diabetic patients (2). The precise intensity and volume of aerobic exercise needed to produce the most wanted effects on targeted risk factors for subjects at risk of/with established type 2 diabetes, is still uncertain. In this study the investigators will investigate the acute effects of a single bout of moderate versus high intensity exercise on insulin sensitivity in pregnant women with and without gestational diabetes mellitus (GDM). The investigators think that very short bouts of high intensity exercise can be a way to reduce blood glucose in these women.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes, Gestational
Behavioral: exercise
  • Experimental: High intensity exercise
    High intensity, short duration exercise on bike
    Intervention: Behavioral: exercise
  • Experimental: Moderate exercise
    Moderate intensity exercise training on bike
    Intervention: Behavioral: exercise
  • No Intervention: No exercise
    No exercise, resting in the lab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
February 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • pregnant
  • Gestational diabetes mellitus or normal glucose tolerance
  • able to exercise

Exclusion Criteria:

-

Female
18 Years to 40 Years
Yes
Contact: trine Moholdt, PhD trine.moholdt@ntnu.no
Contact: siv Mørkved, PhD prof siv.morkved@ntnu.no
Norway
 
NCT01961401
2012/1021
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: trine Moholdt, PhD Norwegian University of Science and Technology
Norwegian University of Science and Technology
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP