We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Fasting II Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01792986
First Posted: February 15, 2013
Last Update Posted: March 20, 2017
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.
Collaborator:
Intermountain Research and Medical Foundation
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
  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 once per week for 6 weeks

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Preparatory Study to Determine Which Risk Markers May be Reduced by Fasting and Should be Evaluated in a Future Randomized Trial

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

Primary Outcome Measures:
  • Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Difference in Weight Between Baseline and the End of the Sixth Week [ Time Frame: 6 weeks ]
  • Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week. [ Time Frame: 6 weeks ]
  • Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week. [ Time Frame: 6 weeks ]
  • Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week. [ Time Frame: 6 weeks ]

Enrollment: 12
Study Start Date: February 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
water-only 24-hour fasting once per week for 6 weeks Behavioral: water-only 24-hour fasting once per week for 6 weeks

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 hemoglobin A1c (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 body mass index (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
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): 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

Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01792986     History of Changes
Other Study ID Numbers: 1024469
First Submitted: February 12, 2013
First Posted: February 15, 2013
Results First Submitted: December 9, 2016
Results First Posted: February 3, 2017
Last Update Posted: March 20, 2017
Last Verified: July 2013

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

Additional relevant MeSH terms:
Metabolic Diseases