Insulin Sensitivity Response to High-Intensity Training in Insulin Resistance During Pregnancy
Impact of High-Intensity Interval Training on Insulin Resistance During Pregnancy: A Randomized Control Trial.
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 5, 2021
CompletedJanuary 19, 2023
January 1, 2023
7 months
April 1, 2021
January 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting blood glucose level
Fasting blood glucose level were measured by expert specialist before and after intervention period from 24th to 37th weeks of pregnancy.
three months
Secondary Outcomes (1)
Fasting Insulin Level
three months
Study Arms (2)
diet program
EXPERIMENTALmoderate restricted diet (1800-2000 kcal/day) for four weeks, 3 sessions weekly
high intensity interval training
EXPERIMENTALhigh intensity interval training for four weeks, 3 sessions weekly
Interventions
high intensity interval training 3 sessions for four weeks
Eligibility Criteria
You may qualify if:
- forty multigravida females.
- their age ranged between 25 to 35 years old.
- Body mass index (BMI) \<30kg/ m².
You may not qualify if:
- females with pelvic pathology as endometriosis.
- females have irregular menstrual cycles.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- Heba mohamed Embabycollaborator
- Salwa Elgendycollaborator
Study Sites (1)
Ghada Elrefaye
Giza, 12613, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Randomization was done by sealed envelope
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt
Study Record Dates
First Submitted
April 1, 2021
First Posted
April 5, 2021
Study Start
March 24, 2020
Primary Completion
October 30, 2020
Study Completion
November 1, 2020
Last Updated
January 19, 2023
Record last verified: 2023-01