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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03938441
Recruitment Status : Terminated (Slow enrollment and PI Graduating Residency in June 2021.)
First Posted : May 6, 2019
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
gino gaddini, Mike O'Callaghan Military Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Pre-diabetes Other: Intermittent Fasting Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biweekly Interval Intermittent Fasting for Type 2 Diabetes, a Safety Study
Actual Study Start Date : July 31, 2019
Actual Primary Completion Date : May 28, 2021
Actual Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intermittent Fasting
Modified 5:2 intermittent fasting
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of hypoglycemic events [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938441


Locations
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United States, Nevada
Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, United States, 89191
Sponsors and Collaborators
gino gaddini
Investigators
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Study Director: Paul F Crawford, MD US Air Force
More Information
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Publications:
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.

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Responsible Party: gino gaddini, Principal Investigator, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT03938441    
Other Study ID Numbers: FWH20190059H
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan on sharing data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Diabetes Mellitus, Type 2
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases