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

Primary Purpose

Intermittent Fasting, Gestational Diabetes, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intermittent fasting diet
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intermittent Fasting

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    study group

    control group

    Arm Description

    • 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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 13, 2021
    Last Updated
    July 18, 2021
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04853537
    Brief Title
    Intermittent Fasting on the Incidence of Gestational Diabetes Mellitus Obese Pregnant Women in 3rd Trimester
    Official Title
    Impact of Intermittent Fasting on the Incidence of Gestational Diabetes Mellitus(DM) in Obese Pregnant Women in 3rd Trimester
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2021 (Anticipated)
    Primary Completion Date
    November 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intermittent Fasting, Gestational Diabetes, Obesity

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    252 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    • 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
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    • 126 women will not fasting with the same life style and follow the incidence of gestational diabetes
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    intermittent fasting diet
    Intervention Description
    intermittent fasting diet to obese pregnant women >30 BMI and incidence of gestational diabetes
    Primary Outcome Measure Information:
    Title
    gestational diabetes
    Description
    percentage of diabetes in obese patient is increased by 1.3% and it will be assessed by glucose tolerance test
    Time Frame
    from 24-36 weeks of gestation
    Secondary Outcome Measure Information:
    Title
    Maternal weight gain,
    Description
    maternal
    Time Frame
    from 24-36 weeks of gestation
    Title
    Fetal weight
    Description
    fetal out come during delivery
    Time Frame
    on labour
    Title
    fetal Apgar score
    Description
    score for baby after labour
    Time Frame
    on labour
    Title
    NICU(neonatal intensive care unit) admission
    Description
    fetal
    Time Frame
    on labour
    Title
    mode of delivery
    Description
    NVD NVD(normal vaginal delivery) or C.S(caesarian section)
    Time Frame
    on 36 weeks of gestation
    Title
    any associated comorbidities questionnaires
    Description
    if there is other diseases developed like gestational hypertension
    Time Frame
    from 24-36 weeks of gestation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    aya abdelaziz, postgraduat
    Phone
    00201098859115
    Email
    ayazizo93@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    reda mokhtar, lecuterer
    Organizational Affiliation
    Ain Shams University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22742901
    Citation
    Alkandari JR, Maughan RJ, Roky R, Aziz AR, Karli U. The implications of Ramadan fasting for human health and well-being. J Sports Sci. 2012;30 Suppl 1:S9-19. doi: 10.1080/02640414.2012.698298. Epub 2012 Jun 29.
    Results Reference
    background
    PubMed Identifier
    30646030
    Citation
    Carter S, Clifton PM, Keogh JB. Effect of Intermittent Compared With Continuous Energy Restricted Diet on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Noninferiority Trial. JAMA Netw Open. 2018 Jul 6;1(3):e180756. doi: 10.1001/jamanetworkopen.2018.0756.
    Results Reference
    background
    PubMed Identifier
    29405359
    Citation
    Corley BT, Carroll RW, Hall RM, Weatherall M, Parry-Strong A, Krebs JD. Intermittent fasting in Type 2 diabetes mellitus and the risk of hypoglycaemia: a randomized controlled trial. Diabet Med. 2018 May;35(5):588-594. doi: 10.1111/dme.13595. Epub 2018 Feb 27.
    Results Reference
    background
    PubMed Identifier
    30301822
    Citation
    Furmli S, Elmasry R, Ramos M, Fung J. Therapeutic use of intermittent fasting for people with type 2 diabetes as an alternative to insulin. BMJ Case Rep. 2018 Oct 9;2018:bcr2017221854. doi: 10.1136/bcr-2017-221854.
    Results Reference
    background
    PubMed Identifier
    31003482
    Citation
    Grajower MM, Horne BD. Clinical Management of Intermittent Fasting in Patients with Diabetes Mellitus. Nutrients. 2019 Apr 18;11(4):873. doi: 10.3390/nu11040873.
    Results Reference
    background
    PubMed Identifier
    20395581
    Citation
    Kim SY, England L, Wilson HG, Bish C, Satten GA, Dietz P. Percentage of gestational diabetes mellitus attributable to overweight and obesity. Am J Public Health. 2010 Jun;100(6):1047-52. doi: 10.2105/AJPH.2009.172890. Epub 2010 Apr 15.
    Results Reference
    background
    PubMed Identifier
    29419624
    Citation
    Harris L, Hamilton S, Azevedo LB, Olajide J, De Brun C, Waller G, Whittaker V, Sharp T, Lean M, Hankey C, Ells L. Intermittent fasting interventions for treatment of overweight and obesity in adults: a systematic review and meta-analysis. JBI Database System Rev Implement Rep. 2018 Feb;16(2):507-547. doi: 10.11124/JBISRIR-2016-003248.
    Results Reference
    background
    PubMed Identifier
    23171320
    Citation
    Klempel MC, Kroeger CM, Bhutani S, Trepanowski JF, Varady KA. Intermittent fasting combined with calorie restriction is effective for weight loss and cardio-protection in obese women. Nutr J. 2012 Nov 21;11:98. doi: 10.1186/1475-2891-11-98.
    Results Reference
    background
    PubMed Identifier
    24810552
    Citation
    Sakar MN, Gultekin H, Demir B, Bakir VL, Balsak D, Vuruskan E, Acar H, Yucel O, Yayla M. Ramadan fasting and pregnancy: implications for fetal development in summer season. J Perinat Med. 2015 May;43(3):319-23. doi: 10.1515/jpm-2013-0289.
    Results Reference
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    PubMed Identifier
    28202779
    Citation
    Wei M, Brandhorst S, Shelehchi M, Mirzaei H, Cheng CW, Budniak J, Groshen S, Mack WJ, Guen E, Di Biase S, Cohen P, Morgan TE, Dorff T, Hong K, Michalsen A, Laviano A, Longo VD. Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease. Sci Transl Med. 2017 Feb 15;9(377):eaai8700. doi: 10.1126/scitranslmed.aai8700.
    Results Reference
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    Intermittent Fasting on the Incidence of Gestational Diabetes Mellitus Obese Pregnant Women in 3rd Trimester

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