N/A
N=12
The Fasting II Study
Diabetes · Metabolic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01792986 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week. — 104.7; 104.5 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- water-only 24-hour fasting once per week for 6 weeks (Behavioral)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Intermountain Health Care, Inc.
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week. |
104.7; 104.5 | — |
| SECONDARY Difference in Weight Between Baseline and the End of the Sixth Week |
92.5; 90.9 | — |
| SECONDARY Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week. |
100.9; 87.8 | — |
| SECONDARY Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week. |
0.69; 0.51 | — |
| SECONDARY Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week. |
4.82; 4.78 | — |
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 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).
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant female, ≥30 and 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 inches (102 cm) for males or >35 inches (88 cm) for females (or body mass index >25 kg/m2).
Exclusion Criteria
- 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) ( 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.
Data sourced from ClinicalTrials.gov (NCT01792986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.