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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

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

Clinicaltrials.gov identifier NCT03938441

Recruitment Status Not yet recruiting

First Posted May 6, 2019

Last update posted July 5, 2019

Study Description

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:Diabetes Type 2
    Pre-diabetes
  • Intervention/Treatment: Other: Intermittent Fasting
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • 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
  • Estimated Study Start Date: July 2019
  • Estimated Primary Completion Date: July 2020
  • Estimated Study Completion Date: July 2020
Arms and interventions
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
  • 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
  • Ages Eligible for Study: 18 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
Contacts

Contact: Jill M Clark, MBA 7026533298 Jill.M.Clark15.ctr@mail.mil

Locations
Sponsors and Collaborators

Seth Leavitt

Investigators

Study Director: Paul F Crawford, MD US Air Force

More Information