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Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Gestational Diabetes Mellitus (GDMakutt)

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ClinicalTrials.gov Identifier: NCT01961401
Recruitment Status : Recruiting
First Posted : October 11, 2013
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes, Gestational Behavioral: exercise

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Pregnant Women With and Without Gestational Diabetes Mellitus
Study Start Date : January 2013
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: High intensity exercise
High intensity, short duration exercise on bike
Behavioral: exercise
Experimental: Moderate exercise
Moderate intensity exercise training on bike
Behavioral: exercise
No Intervention: No exercise
No exercise, resting in the lab


Outcome Measures

Primary Outcome Measures :
  1. insulin sensitivity [ Time Frame: 1 day ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961401


Contacts
Contact: trine Moholdt, PhD trine.moholdt@ntnu.no
Contact: siv Mørkved, PhD prof siv.morkved@ntnu.no

Locations
Norway
Department of circulation and medical imaging Recruiting
Trondheim, Norway
Contact: Kari M Lundgren       kari_m_lundgren@yahoo.com   
Contact: trine moholdt, PhD       trine.moholdt@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: trine Moholdt, PhD Norwegian University of Science and Technology
More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01961401     History of Changes
Other Study ID Numbers: 2012/1021
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Norwegian University of Science and Technology:
exercise
exercise therapy
insulin resistance

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Pregnancy Complications
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs