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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Type 2, Pre-diabetes

Intervention / Treatment
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* Other: Intermittent Fasting


Participation Criteria
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Eligibility Criteria
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**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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent Fasting<br>Modified 5:2 intermittent fasting | Other: Intermittent Fasting<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |