Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Fasting II Study

This study has been completed.
Sponsor:
Collaborator:
Intermountain Research and Medical Foundation
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01792986
First received: February 12, 2013
Last updated: August 1, 2013
Last verified: July 2013

February 12, 2013
August 1, 2013
February 2013
June 2013   (final data collection date for primary outcome measure)
Difference in mean hemoglobin A1c level between baseline and the end of the fifth week. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01792986 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Fasting II Study
Preparatory Study to Determine Which Risk Markers May be Reduced by Fasting and Should be Evaluated in a Future Randomized Trial

This study will determine whether an intensive fasting protocol alters hemoglobin A1c measurements or other markers of metabolic and cardiovascular risk by performing a 5-week clinical trial of fasting among 12 pre-diabetic individuals or diabetics whose disease is controlled by diet. Participants will undergo a 5-week intervention of once-per-week 24-hour water-only fasting, including at baseline and at the end of the week for each week of the study (a total of 6 24-hour fasts).

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Diabetes
  • Metabolic Diseases
Behavioral: water-only 24-hour fasting
water-only 24-hour fasting
Intervention: Behavioral: water-only 24-hour fasting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Not Provided
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or non-pregnant female, ≥30 and <70 years of age.
  2. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
  3. Prior evidence of pre-diabetic state, with one of the following:

    1. Pre-diabetic with a measured HbA1c ≥6.0% or fasting glucose >100 mg/dL without a clinical diabetes diagnosis
    2. Clinically-diagnosed type II diabetic with HbA1c ≥6.0% or fasting glucose ≥110 mg/dL and whose disease is controlled by diet alone.
  4. Evidence of metabolic syndrome by having at least 3 of the following 5 criteria:

    1. Fasting glucose level >100 mg/dL.
    2. Blood pressure ≥135 mmHg systolic or ≥85 mmHg diastolic, or use of an antihypertensive medication.
    3. High-density lipoprotein cholesterol <40 mg/dL in males or <50 mg/dL in females.
    4. Triglycerides ≥150 mg/dL or use of a cholesterol-lowering medication.
    5. Waist circumference >40 inches (102 cm) for males or >35 inches (88 cm) for females (or body mass index >25 kg/m2).

Exclusion Criteria:

  1. Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Principal Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
  2. Diabetics taking any of the following anti-diabetic medications: insulin, metformin, thiazolidinediones, sulfonylureas, alpha-glucosidase inhibitors, meglitinides, or incretins.
  3. Prior experience with fasting more than once per month (for 20 hours or more), on average during the last year.
  4. Very low BMI (<18.5 kg/m2) or high BMI (>40 kg/m2).
  5. Individuals who are nutritionally compromised, as assessed by the Principal Investigator.
  6. Any immunodeficiency or prior solid organ transplantation or renal disease.
  7. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
  8. Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
Both
30 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01792986
1024469
No
Intermountain Health Care, Inc.
Intermountain Health Care, Inc.
Intermountain Research and Medical Foundation
Principal Investigator: Benjamin D Horne, PhD, MPH Intermountain Health Care, Inc.
Intermountain Health Care, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP