NCT04830995

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

April 1, 2021

Last Update Submit

January 18, 2023

Conditions

Keywords

TrainingInsulin ResistancePregnancy

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

EXPERIMENTAL

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

EXPERIMENTAL

high intensity interval training for four weeks, 3 sessions weekly

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

Interventions

high intensity interval training 3 sessions for four weeks

Also known as: high intensity interval training
diet programhigh intensity interval training

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Ghada Elrefaye

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

Locations