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Intermittent Fasting on the Incidence of Gestational Diabetes Mellitus Obese Pregnant Women in 3rd Trimester

Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04853537
Collaborator
(none)
252
Enrollment
2
Arms
4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This randomized controlled clinical trial will assess the impact of intermittent fasting on the incidence of gestational DM in obese pregnant women in 3rd trimester and its effect on maternal and neonatal outcomes.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: intermittent fasting diet
 N/A

Detailed Description

The term intermittent fasting, when used for health reasons or weight loss, has been used to describe various types of caloric restriction. Some authors use it when a patient withholds caloric intake for several consecutive hours during the day (often 16 h with all energy intake during the other 8 h of the day, others for a full day once or twice a week , and others three or four days per week Some protocols allow protein intake but no carbohydrates and still label it intermittent fasting.

Others allow carbohydrates or macro/micro-nutrients up to a limit that will still promote ketosis and, although it is simply a low-calorie diet, due to the popularity of fasting this has been labeled a diet that mimics fasting.

In this protocol we use 16hour fasting in 24hour with the same caloric intake in 8hour and can drink water ,coffee , and other noncaloric beverages during the fast, which can help reduce feelings of hunger .

In all instances, non-caloric fluid intake is permitted (which is one of the main differences when compared to religious fasting) and therefore significantly reduces the risk of dehydration and hypotension, a prominent consideration in religious fasting.

During the fasting hours and after breaking the fast, metabolic condition of the body could be influenced as a consequence of change in the pattern and amount of activity, meals and fluid intake, and even sleeping hours.

Intermittent fasting and low caloric intake have been shown to improve various metabolic and inflammatory pathways. Insulin resistance, the most prominent feature of type 2 diabetes during pregnancy, has long been known to improve with intermittent fasting. After a period of fasting, insulin sensitivity rises and insulin levels fall. These result in improved fasting and postprandial glucose levels. In addition, as insulin induces adipose tissue growth, there is less propensity to weight gain and potentially even weight loss which leading to decrease neonatal adverse effects of gestational DM and improved fetal outcome.

On the other hand, many other studies found that fasting has no effect on intrauterine growth, birth weight, birth-time indices, gestational diabetes, preterm birth, and preeclampsia. Predominantly, results of the studies examining the effects of fasting on mothers and newborns are not homogenous; therefore, further research should be conducted to attain valid findings.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
252 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Impact of Intermittent Fasting on the Incidence of Gestational Diabetes Mellitus(DM) in Obese Pregnant Women in 3rd Trimester
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: study group

• 126 women will fast 16 consecutive hours per day including sleeping hours. and follow them from 26w till 36w by GTT(glucose tolerance test) and the weight gain and incidence of gestational diabetes

Dietary Supplement: intermittent fasting diet
intermittent fasting diet to obese pregnant women >30 BMI and incidence of gestational diabetes
No Intervention: control group

• 126 women will not fasting with the same life style and follow the incidence of gestational diabetes

Outcome Measures

Primary Outcome Measures

  1. gestational diabetes [from 24-36 weeks of gestation]

    percentage of diabetes in obese patient is increased by 1.3% and it will be assessed by glucose tolerance test

Secondary Outcome Measures

  1. Maternal weight gain, [from 24-36 weeks of gestation]

    maternal

  2. Fetal weight [on labour]

    fetal out come during delivery

  3. fetal Apgar score [on labour]

    score for baby after labour

  4. NICU(neonatal intensive care unit) admission [on labour]

    fetal

  5. mode of delivery [on 36 weeks of gestation]

    NVD NVD(normal vaginal delivery) or C.S(caesarian section)

  6. any associated comorbidities questionnaires [from 24-36 weeks of gestation]

    if there is other diseases developed like gestational hypertension

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Healthy pregnant women. 2. Age (18 - 35 years old). 3. Women with BMI (_> 30 kg/m2).
  1. A living singleton pregnancy. Gestational age (24- 27 weeks).(recruitment time)
Exclusion Criteria:
    1. Multiple gestations. 2. Women with diabetes 3. pre-pregnancy cardiovascular disease, chronic hypertensive, and pregnancy-induced hypertension; blood pressure _> 140/90.
  1. Women with hepatic, renal diseases or coagulopathy 5. Women with peptic ulcer.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ain Shams University

Investigators

  • Principal Investigator: reda mokhtar, lecuterer, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ain Shams University
ClinicalTrials.gov Identifier:
NCT04853537
Other Study ID Numbers:
  • effect of IF on GD in obese
First Posted:
Apr 21, 2021
Last Update Posted:
Jul 20, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus

Study Results

No Results Posted as of Jul 20, 2021