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

This study is currently recruiting participants.
Verified November 2017 by Norwegian University of Science and Technology
Sponsor:
ClinicalTrials.gov Identifier:
NCT01961401
First Posted: October 11, 2013
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
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 Intervention
Diabetes, Gestational Behavioral: exercise

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 24
Study Start Date: January 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: October 9, 2013
First Posted: October 11, 2013
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 Mellitus
Insulin Resistance
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Pregnancy Complications
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs