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Insulin Sensitivity Response to High-Intensity Training in Insulin Resistance During Pregnancy

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04830995
Collaborator
Heba mohamed Embaby (Other), Salwa Elgendy (Other)
40
Enrollment
1
Location
2
Arms
7.3
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: moderate restricted diet (1800-2000 kcal/day) for four weeks
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
group (A) received HIIT and low diet for four weeks, 3 sessions weekly. While the control group received diet only.group (A) received HIIT and low diet for four weeks, 3 sessions weekly. While the control group received diet only.
Masking:
Double (Participant, Investigator)
Masking Description:
Randomization was done by sealed envelope
Primary Purpose:
Treatment
Official Title:
Insulin Sensitivity and Plasma Glucose Response to High-Intensity Interval Training in Insulin Resistance During Pregnancy
Actual Study Start Date :
Mar 24, 2020
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: diet program

moderate restricted diet (1800-2000 kcal/day) for four weeks, 3 sessions weekly

Dietary Supplement: moderate restricted diet (1800-2000 kcal/day) for four weeks
high intensity interval training 3 sessions for four weeks
Other Names:
  • high intensity interval training

    		•
    Experimental: high intensity interval training

    high intensity interval training for four weeks, 3 sessions weekly

    Dietary Supplement: moderate restricted diet (1800-2000 kcal/day) for four weeks
    high intensity interval training 3 sessions for four weeks
    Other Names:
  • high intensity interval training

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Fasting blood glucose level [three months]

      Fasting blood glucose level were measured by expert specialist before and after intervention period from 24th to 37th weeks of pregnancy.

    Secondary Outcome Measures

    1. Fasting Insulin Level [three months]

      Fasting blood insulin level were measured by expert specialist before and after intervention period from 24th to 37th weeks of pregnancy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ghada Elrefaye Giza Egypt 12613

    Sponsors and Collaborators

    • Cairo University
    • Heba mohamed Embaby
    • Salwa Elgendy

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ghada Ebrahim El Refaye, assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04830995
    Other Study ID Numbers:
    • Cairo Un100
    First Posted:
    Apr 5, 2021
    Last Update Posted:
    Apr 5, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ghada Ebrahim El Refaye, assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt, Cairo University
    Training
    Insulin Resistance
    Pregnancy
    Additional relevant MeSH terms:
    Insulin Resistance

    Study Results

    No Results Posted as of Apr 5, 2021