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

NCT04853537 | Unknown

• 1 other identifier: effect of IF on GD in obese
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intermittent Fasting; Gestational Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• gestational diabetes

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

  from 24-36 weeks of gestation

Secondary Outcomes (6)

• Maternal weight gain,

  from 24-36 weeks of gestation

• Fetal weight

  on labour

• fetal Apgar score

  on labour

• NICU(neonatal intensive care unit) admission

  on labour

• mode of delivery

  on 36 weeks of gestation

Study Arms (2)

study group

EXPERIMENTAL

• 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

control group

NO INTERVENTION

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

Interventions

intermittent fasting diet DIETARY_SUPPLEMENT

intermittent fasting diet to obese pregnant women \>30 BMI and incidence of gestational diabetes

study group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 1. Healthy pregnant women. 2. Age (18 - 35 years old). 3. Women with BMI (\_\> 30 kg/m2).
• \. A living singleton pregnancy. Gestational age (24- 27 weeks).(recruitment time)

You may not qualify if:

• \- 1. Multiple gestations. 2. Women with diabetes 3. pre-pregnancy cardiovascular disease, chronic hypertensive, and pregnancy-induced hypertension; blood pressure \_\> 140/90.
• \. Women with hepatic, renal diseases or coagulopathy 5. Women with peptic ulcer.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (10)

• 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.

  PMID: 22742901 BACKGROUND

• 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.

  PMID: 30646030 BACKGROUND

• 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.

  PMID: 29405359 BACKGROUND

• 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.

  PMID: 30301822 BACKGROUND

• 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.

  PMID: 31003482 BACKGROUND

• 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.

  PMID: 20395581 BACKGROUND

• 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.

  PMID: 29419624 BACKGROUND

• 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.

  PMID: 23171320 BACKGROUND

• 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.

  PMID: 24810552 BACKGROUND

• 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.

  PMID: 28202779 BACKGROUND

MeSH Terms

Conditions

Intermittent Fasting; Diabetes, Gestational; Obesity

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• reda mokhtar, lecuterer

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

aya abdelaziz, postgraduat

CONTACT

00201098859115; ayazizo93@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 21, 2021
• Study Start: August 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-04