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

NCT01961401 | Terminated

• 1 other identifier: 2012/1021
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes, Gestational

Keywords

exercise; exercise therapy; insulin resistance

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity

  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.

  1 day

Study Arms (3)

High intensity exercise

EXPERIMENTAL

High intensity, short duration exercise on bike

Behavioral: exercise

Moderate exercise

EXPERIMENTAL

Moderate intensity exercise training on bike

Behavioral: exercise

No exercise

NO INTERVENTION

No exercise, resting in the lab

Interventions

exercise BEHAVIORAL

High intensity exercise; Moderate exercise

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Department of circulation and medical imaging

Trondheim, Norway

Location

MeSH Terms

Conditions

Diabetes, Gestational; Motor Activity; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• trine Moholdt, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

NO (1)