Biweekly Interval Intermittent Fasting for Type 2 Diabetes, a Safety Study
NCT ID: NCT03938441
Last Updated: 2021-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
24 participants
INTERVENTIONAL
2019-07-31
2021-05-28
Brief Summary
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Detailed Description
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In the effort to improve compliance of lifetime dietary change, the version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies.
On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories.
Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intermittent Fasting
Modified 5:2 intermittent fasting
Intermittent Fasting
The version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies.
On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories.
Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day.
Interventions
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Intermittent Fasting
The version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies.
On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories.
Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Type 2 Diabetes or pre-diabetic
* Prescribed/taking Metformin 500mg to 2000mg daily
Exclusion Criteria
* Drugs/medication with known increase in hypoglycemic events \[Include basal insulin, rapid acting insulin, sulfonylureas, etc.). Metformin is not known to cause hypoglycemia.
* Pregnant
* Medication-induced or secondary diabetes
* Known abnormal hematocrit
18 Years
69 Years
ALL
No
Sponsors
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gino gaddini
FED
Responsible Party
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gino gaddini
Principal Investigator
Principal Investigators
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Paul F Crawford, MD
Role: STUDY_DIRECTOR
US Air Force
Locations
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Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, United States
Countries
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References
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Carter S, Clifton PM, Keogh JB. The effects of intermittent compared to continuous energy restriction on glycaemic control in type 2 diabetes; a pragmatic pilot trial. Diabetes Res Clin Pract. 2016 Dec;122:106-112. doi: 10.1016/j.diabres.2016.10.010. Epub 2016 Oct 19.
Arnason TG, Bowen MW, Mansell KD. Effects of intermittent fasting on health markers in those with type 2 diabetes: A pilot study. World J Diabetes. 2017 Apr 15;8(4):154-164. doi: 10.4239/wjd.v8.i4.154.
Azevedo FR, Ikeoka D, Caramelli B. Effects of intermittent fasting on metabolism in men. Rev Assoc Med Bras (1992). 2013 Mar-Apr;59(2):167-73. doi: 10.1016/j.ramb.2012.09.003.
Ash S, Reeves MM, Yeo S, Morrison G, Carey D, Capra S. Effect of intensive dietetic interventions on weight and glycaemic control in overweight men with Type II diabetes: a randomised trial. Int J Obes Relat Metab Disord. 2003 Jul;27(7):797-802. doi: 10.1038/sj.ijo.0802295.
Horne BD, Muhlestein JB, Anderson JL. Health effects of intermittent fasting: hormesis or harm? A systematic review. Am J Clin Nutr. 2015 Aug;102(2):464-70. doi: 10.3945/ajcn.115.109553. Epub 2015 Jul 1.
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.
Genuth S, Eastman R, Kahn R, Klein R, Lachin J, Lebovitz H, Nathan D, Vinicor F; American Diabetes Association. Implications of the United kingdom prospective diabetes study. Diabetes Care. 2003 Jan;26 Suppl 1:S28-32. doi: 10.2337/diacare.26.2007.s28. No abstract available.
Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2015.
Other Identifiers
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FWH20190059H
Identifier Type: -
Identifier Source: org_study_id
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