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Completed

NCT Number: NCT04830995

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

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.

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Key information

Conditions

High Intensity Interval Training Diet, Healthy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ghada Elrefaye

Giza, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary Supplement

high intensity interval training 3 sessions for four weeks

Other names: high intensity interval training

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Heba mohamed Embaby
  • Salwa Elgendy

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2021
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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