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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. (see Contacts and Locations)
Verified October 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: October 27, 2014
Last verified: October 2014
  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: 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 ] [ 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.


Estimated Enrollment: 24
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01961401     History of Changes
Other Study ID Numbers: 2012/1021
Study First Received: October 9, 2013
Last Updated: October 27, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on November 25, 2014