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

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ClinicalTrials.gov Identifier: NCT04853537
Recruitment Status : Not yet recruiting
First Posted : April 21, 2021
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intermittent Fasting Gestational Diabetes Obesity Dietary Supplement: intermittent fasting diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. gestational diabetes [ Time Frame: 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, [ Time Frame: from 24-36 weeks of gestation ]
    maternal

  2. Fetal weight [ Time Frame: on labour ]
    fetal out come during delivery

  3. fetal Apgar score [ Time Frame: on labour ]
    score for baby after labour

  4. NICU(neonatal intensive care unit) admission [ Time Frame: on labour ]
    fetal

  5. mode of delivery [ Time Frame: on 36 weeks of gestation ]
    NVD NVD(normal vaginal delivery) or C.S(caesarian section)

  6. any associated comorbidities questionnaires [ Time Frame: from 24-36 weeks of gestation ]
    if there is other diseases developed like gestational hypertension



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853537


Contacts
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Contact: aya abdelaziz, postgraduat 00201098859115 ayazizo93@gmail.com

Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: reda mokhtar, lecuterer Ain Shams University
Publications:

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Responsible Party: Ain Shams University
ClinicalTrials.gov Identifier: NCT04853537    
Other Study ID Numbers: effect of IF on GD in obese
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications