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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04830995
Other study ID # Cairo Un100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 24, 2020
Est. completion date November 1, 2020

Study information

Verified date January 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 1, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 35 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Egypt Ghada Elrefaye Giza

Sponsors (3)

Lead Sponsor Collaborator
Cairo University Heba mohamed Embaby, Salwa Elgendy

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Fasting Insulin Level Fasting blood insulin level were measured by expert specialist before and after intervention period from 24th to 37th weeks of pregnancy. three months
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