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

Not Applicable

Terminated

• Conditions: Diabetes Type 2; Pre-diabetes
• Interventions: Other: Intermittent Fasting

• Registration Number: NCT03938441
• Lead Sponsor: gino gaddini

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.

Study Timeline

• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Study Start: 2019-07-31
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intermittent Fasting	Intermittent Fasting	Modified 5:2 intermittent fasting

Primary Outcome Measures

Name	Time	Method
Number of hypoglycemic events	Number will vary depending on the number of hypoglycaemic events per each subject and will be recorded throughout study until completion at 12 weeks	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.

Trial Locations

Locations (1)

Mike O'Callaghan Military Medical Center; 🇺🇸 Nellis Air Force Base, Nevada, United States