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

Not Applicable

• Conditions: Intermittent Fasting; Gestational Diabetes; Obesity
• Interventions: Dietary Supplement: intermittent fasting diet

• Registration Number: NCT04853537
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-21
• Last Update Submitted: 2021-07-18
• Last Update Posted: 2021-07-20
• Study Start: 2021-08
• Primary Completion: 2021-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 252

Inclusion Criteria

• 1. Healthy pregnant women. 2. Age (18 - 35 years old). 3. Women with BMI (_> 30 kg/m2).

4. A living singleton pregnancy. Gestational age (24- 27 weeks).(recruitment time)

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Exclusion Criteria

• 1. Multiple gestations. 2. Women with diabetes 3. pre-pregnancy cardiovascular disease, chronic hypertensive, and pregnancy-induced hypertension; blood pressure _> 140/90.

4. Women with hepatic, renal diseases or coagulopathy 5. Women with peptic ulcer.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	intermittent fasting diet	• 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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Maternal weight gain,	from 24-36 weeks of gestation	maternal
Fetal weight	on labour	fetal out come during delivery
fetal Apgar score	on labour	score for baby after labour
NICU(neonatal intensive care unit) admission	on labour	fetal
mode of delivery	on 36 weeks of gestation	NVD NVD(normal vaginal delivery) or C.S(caesarian section)
any associated comorbidities questionnaires	from 24-36 weeks of gestation	if there is other diseases developed like gestational hypertension