Not provided
Not provided
Not provided
Not provided
Not provided
Slow enrollment and PI Graduating Residency in June 2021.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Fasting | Experimental | Modified 5:2 intermittent fasting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Fasting | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
**Subjects must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul F Crawford, MD | US Air Force | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Military Medical Center | Nellis Air Force Base | Nevada | 89191 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27833048 | Background | 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. | |
| 28465792 | Background | 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. |
Not provided
Not provided
We do not plan on sharing data
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 23582559 | Background | 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. |
| 12821964 | Background | 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. |
| 26135345 | Background | 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. |
| 29405359 | 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. |
| 12502617 | Background | 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. |
| Background | 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. |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |