Status:
COMPLETED
The Fasting II Study
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborating Sponsors:
Intermountain Research and Medical Foundation
Conditions:
Diabetes
Metabolic Diseases
Eligibility:
All Genders
30-69 years
Phase:
NA
Brief Summary
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 fastin...
Eligibility Criteria
Inclusion
- Male or non-pregnant female, ≥30 and \<70 years of age.
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- Prior evidence of pre-diabetic state, with one of the following:
- Pre-diabetic with a measured hemoglobin A1c (HbA1c) ≥6.0% or fasting glucose \>100 mg/dL without a clinical diabetes diagnosis
- Clinically-diagnosed type II diabetic with HbA1c ≥6.0% or fasting glucose ≥110 mg/dL and whose disease is controlled by diet alone.
- Evidence of metabolic syndrome by having at least 3 of the following 5 criteria:
- Fasting glucose level \>100 mg/dL.
- Blood pressure ≥135 mmHg systolic or ≥85 mmHg diastolic, or use of an antihypertensive medication.
- High-density lipoprotein cholesterol \<40 mg/dL in males or \<50 mg/dL in females.
- Triglycerides ≥150 mg/dL or use of a cholesterol-lowering medication.
- Waist circumference \>40 inches (102 cm) for males or \>35 inches (88 cm) for females (or body mass index \>25 kg/m2).
Exclusion
- 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.
- Diabetics taking any of the following anti-diabetic medications: insulin, metformin, thiazolidinediones, sulfonylureas, alpha-glucosidase inhibitors, meglitinides, or incretins.
- Prior experience with fasting more than once per month (for 20 hours or more), on average during the last year.
- Very low body mass index (BMI) (\<18.5 kg/m2) or high BMI (\>40 kg/m2).
- Individuals who are nutritionally compromised, as assessed by the Principal Investigator.
- Any immunodeficiency or prior solid organ transplantation or renal disease.
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01792986
Start Date
February 1 2013
End Date
June 1 2013
Last Update
March 20 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Intermountain Medical Center
Murray, Utah, United States, 84107
2
Intermountain Medical Center
Salt Lake City, Utah, United States, 84107