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
  Purpose

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).


Condition Intervention
Diabetes
Metabolic Diseases
Behavioral: water-only 24-hour fasting

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Preparatory Study to Determine Which Risk Markers May be Reduced by Fasting and Should be Evaluated in a Future Randomized Trial

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Difference in mean hemoglobin A1c level between baseline and the end of the fifth week. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: February 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
water-only 24-hour fasting Behavioral: water-only 24-hour fasting

  Eligibility

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792986

Locations
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
Intermountain Medical Center
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Intermountain Health Care, Inc.
Intermountain Research and Medical Foundation
Investigators
Principal Investigator: Benjamin D Horne, PhD, MPH Intermountain Health Care, Inc.
  More Information

No publications provided

Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01792986     History of Changes
Other Study ID Numbers: 1024469
Study First Received: February 12, 2013
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
Diabetes
Fasting
Pre-diabetes
Hemoglobin A1C

Additional relevant MeSH terms:
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014