Clinical trial NCT03938441: Biweekly Interval Intermittent Fasting for Type 2 Diabetes, a Safety Study
Official title: Biweekly Interval Intermittent Fasting for Type 2 Diabetes, a Safety Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Type 2
Pre-diabetes
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2019-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish safety of biweekly intermittent fasting in the setting of type 2 diabetes mellitus or prediabetes under treatment with non-hypoglycemic agents (e.g. metformin).

Detailed description: This study is proposed as a prospective interventional cohort safety study for biweekly intermittent fasting.

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.

Eligibility criteria: \*\*Subjects must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Male and female Active Duty members and DoD beneficiaries ages 18-69
* Diagnosed with Type 2 Diabetes or pre-diabetic
* Prescribed/taking Metformin 500mg to 2000mg daily

Exclusion Criteria:

* History of recurrent hypoglycemic events on present medication regimen
* 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

Primary outcomes:
measure: Number of hypoglycemic events
timeFrame: Number will vary depending on the number of hypoglycaemic events per each subject and will be recorded throughout study until completion at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
affiliation: US Air Force
name: Paul F Crawford, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.