The Fasting II Study
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 69 |
| Updated: | 7/16/2013 |
| Start Date: | February 2013 |
| Contact: | Benjamin D Horne, PhD, MPH |
| Email: | benjamin.horne@imail.org |
| Phone: | (801) 507-4708 |
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).
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.
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