Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT06111040 - Nurturing Needs Study: Parenting Food Motivated Children N/A
Completed NCT06299072 - A Cross-sectional Online Survey Among Saudi Arabian Population in the Age Group 18-40 Years to Assess Whole Grain (WG) Awareness, Consumption Levels, and Dietary Habits Around Breakfast
Recruiting NCT05863559 - Super Chef - an Online Program Promoting the Mediterranean Dietary Pattern to Lower Income Families N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Not yet recruiting NCT05783141 - Prebiotic Effects in Healthy Toddlers N/A
Not yet recruiting NCT05934968 - Mad Dog Cooking Class Series: Effects on Dietary Self-efficacy, Eating Behaviors and Health Outcomes N/A
Active, not recruiting NCT05544461 - Piloting a Web-based Personalised Nutrition App (eNutri) With UK University Students N/A
Active, not recruiting NCT04991142 - Models of Nutrition From Continuous Glucose Monitors
Recruiting NCT04946448 - COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study N/A
Not yet recruiting NCT06464497 - Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity N/A
Terminated NCT04067362 - Chicory Fiber Effect on Satiety and GI Tolerance N/A
Completed NCT04084028 - Cooking as a Health Behavior in College Students N/A
Recruiting NCT05512247 - Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During Pregnancy N/A
Recruiting NCT06145009 - Time Restricted Eating, Eating Behaviors, and Cardiometabolic Risk in Emerging Adult Women N/A
Recruiting NCT06022302 - Effects of Changing Intestinal Transit Time on Gut Microbial Composition and Metabolism N/A
Completed NCT05173376 - SEP and the Impact of Portion Size on Daily Energy Intake N/A
Recruiting NCT04374747 - Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk N/A
Recruiting NCT04876053 - Home Food Delivery for Diabetes Management in Patients of Rural Clinics N/A
Not yet recruiting NCT06298253 - Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2 N/A
Not yet recruiting NCT05566587 - Designing a Personalized Diet to Reduce the Risk of Crohn's Disease Onset N/A