- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04830995
Insulin Sensitivity Response to High-Intensity Training in Insulin Resistance During Pregnancy
January 18, 2023 updated by: Ghada Ebrahim El Refaye, Cairo University
Impact of High-Intensity Interval Training on Insulin Resistance During Pregnancy: A Randomized Control Trial.
Insulin Resistance is one of the common complications that occur during pregnancy.
Early intervention is essential to prevent the development of the diseaseThere is evidence that physical inactivity increases the risk of a lot of adverse health problems, including coronary heart disease, type 2 diabetes, breast and colon cancers.
It also shortens life expectancy.
Pregnancy is a period in the life of women that is often associated with decreased daily physical activity and decreased participation in sports and exercise .
In the first few weeks of pregnancy, maternal carbohydrate metabolism is affected by a rise in maternal levels of estrogen and progesterone that stimulates pancreatic β-cell hyperplasia and insulin secretion.
As pregnancy progress, pancreatic islet cell hypertrophy continues and there is an increased insulin response to glucose or meal stimulation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was carried out upon twenty multigravida pregnant female between 5-6 months gestation with IR calculated by HOMA test (fasting blood glucose× fasting insulin) ÷ 22.5.
Fasting blood glucose was assessed by the method approved by (7, 13) .The test materials for this method were supplied as kits by "Diamond Diagnostics," while Insulin concentrations were stated in formerly frozen and defrosted serum samples by enzyme immunoassay using the human Insulin ELISA kits.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt, 12613
- Ghada Elrefaye
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- forty multigravida females.
- their age ranged between 25 to 35 years old.
- Body mass index (BMI) <30kg/ m².
Exclusion Criteria:
- females with pelvic pathology as endometriosis.
- females have irregular menstrual cycles.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: diet program
moderate restricted diet (1800-2000 kcal/day) for four weeks, 3 sessions weekly
|
high intensity interval training 3 sessions for four weeks
Other Names:
|
Experimental: high intensity interval training
high intensity interval training for four weeks, 3 sessions weekly
|
high intensity interval training 3 sessions for four weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting blood glucose level
Time Frame: three months
|
Fasting blood glucose level were measured by expert specialist before and after intervention period from 24th to 37th weeks of pregnancy.
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting Insulin Level
Time Frame: three months
|
Fasting blood insulin level were measured by expert specialist before and after intervention period from 24th to 37th weeks of pregnancy.
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 24, 2020
Primary Completion (Actual)
October 30, 2020
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
April 1, 2021
First Submitted That Met QC Criteria
April 1, 2021
First Posted (Actual)
April 5, 2021
Study Record Updates
Last Update Posted (Estimate)
January 19, 2023
Last Update Submitted That Met QC Criteria
January 18, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cairo Un100
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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