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

gino gaddini

Status: Terminated

Conditions: Pre-diabetes; Diabetes Type 2

Treatments: Other: Intermittent Fasting

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03938441

FWH20190059H

Details and patient eligibility

About

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).

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Intermittent Fasting

Experimental group

Description:

Modified 5:2 intermittent fasting

Treatment:

Other: Intermittent Fasting