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TerminatedNCT01961401GDMakuttUpdated Apr 9, 2018

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

An interventional study of exercise in Diabetes, Gestational, sponsored by Norwegian University of Science and Technology. Terminated at 1 site in Norway. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-09.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to recruitment problems
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

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Conditions studied

  • Diabetes, Gestational

Keywords

  • exercise
  • exercise therapy
  • insulin resistance
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In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 9 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • 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

Interventions

  • Behavioralexercise
06

What researchers measure

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.

    Time frame: 1 day

07

Study locations

1 site
  • Department of circulation and medical imaging
    Trondheim, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01961401
Lead sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
Responsible party
Sponsor
First posted
Oct 11, 2013
Start date
Jan 2013
Primary completion
Feb 2018
Completion
Feb 2018
Last update
Apr 9, 2018

Study contacts

trine Moholdt, PhD
principal investigator · Norwegian University of Science and Technology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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