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

Primary Purpose

High Intensity Interval Training, Diet, Healthy

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

moderate restricted diet (1800-2000 kcal/day) for four weeks

About this trial

This is an interventional treatment trial for High Intensity Interval Training focused on measuring Training, Insulin Resistance, Pregnancy

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Ghada Elrefaye

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

diet program

high intensity interval training

Arm Description

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

high intensity interval training for four weeks, 3 sessions weekly

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fasting Insulin Level

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

Full Information

NCT ID

NCT04830995

First Posted

April 1, 2021

Last Updated

January 18, 2023

Sponsor

Cairo University

Collaborators

Heba mohamed Embaby, Salwa Elgendy

1. Study Identification

Unique Protocol Identification Number

NCT04830995

Brief Title

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

Official Title

Impact of High-Intensity Interval Training on Insulin Resistance During Pregnancy: A Randomized Control Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

March 24, 2020 (Actual)

Primary Completion Date

October 30, 2020 (Actual)

Study Completion Date

November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

Collaborators

Heba mohamed Embaby, Salwa Elgendy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High Intensity Interval Training, Diet, Healthy

Keywords

Training, Insulin Resistance, Pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

group (A) received HIIT and low diet for four weeks, 3 sessions weekly. While the control group received diet only.

Masking

ParticipantInvestigator

Masking Description

Randomization was done by sealed envelope

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

diet program

Arm Type

Experimental

Arm Description

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

Arm Title

high intensity interval training

Arm Type

Experimental

Arm Description

high intensity interval training for four weeks, 3 sessions weekly

Intervention Type

Dietary Supplement

Intervention Name(s)

moderate restricted diet (1800-2000 kcal/day) for four weeks

Other Intervention Name(s)

high intensity interval training

Intervention Description

high intensity interval training 3 sessions for four weeks

Primary Outcome Measure Information:

Title

Fasting blood glucose level

Description

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

Time Frame

three months

Secondary Outcome Measure Information:

Title

Fasting Insulin Level

Description

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

Time Frame

three months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Ghada Elrefaye

City

Giza

ZIP/Postal Code

12613

Country

Egypt

12. IPD Sharing Statement

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

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