Biweekly Interval Intermittent Fasting for Type 2 Diabetes, a Safety Study

Pre-diabetes Clinical Trial

Official title:

Biweekly Interval Intermittent Fasting for Type 2 Diabetes, a Safety Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03938441
• Other study ID #: FWH20190059H
• Status: Terminated
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: May 28, 2021

Study information

• Verified date: June 2021
• Source: Mike O'Callaghan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

**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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Mike O'Callaghan Military Medical Center	Nellis Air Force Base	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
gino gaddini

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. Review. — View 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. — View 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.

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hypoglycemic events	This study's intent is to investigate the safety of this intervention for use in a broader scope. It is imperative that risks are known for each subpopulation of diabetics. To this point, our literature review indicates that hypoglycemic events did occur at higher rates in fasting populations taking hypoglycemic medications. We intend to look at rates of hypoglycemia on those not on hypoglycemic medications to assess if this trend continues.	Number will vary depending on the number of hypoglycaemic events per each subject and will be recorded throughout study until completion at 12 weeks