Intermittent Fasting on the Incidence of Gestational Diabetes Mellitus Obese Pregnant Women in 3rd Trimester
NCT ID: NCT04853537
Last Updated: 2021-07-20
Study Results
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Basic Information
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UNKNOWN
NA
252 participants
INTERVENTIONAL
2021-08-31
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
intermittent fasting diet
intermittent fasting diet to obese pregnant women \>30 BMI and incidence of gestational diabetes
control group
• 126 women will not fasting with the same life style and follow the incidence of gestational diabetes
No interventions assigned to this group
Interventions
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intermittent fasting diet
intermittent fasting diet to obese pregnant women \>30 BMI and incidence of gestational diabetes
Eligibility Criteria
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Inclusion Criteria
4\. A living singleton pregnancy. Gestational age (24- 27 weeks).(recruitment time)
Exclusion Criteria
4\. Women with hepatic, renal diseases or coagulopathy 5. Women with peptic ulcer.
18 Years
35 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Principal Investigators
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reda mokhtar, lecuterer
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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effect of IF on GD in obese
Identifier Type: -
Identifier Source: org_study_id
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