Insulin Resistance Clinical Trial
— FBHHOfficial title:
A Pilot Study on the Effects of Medically Supervised, Water-Only Fasting and Refeeding on Cardiometabolic Risk
NCT number | NCT04507516 |
Other study ID # | TNHF2018-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2, 2019 |
Est. completion date | February 10, 2020 |
Verified date | August 2020 |
Source | TrueNorth Health Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 10, 2020 |
Est. primary completion date | February 10, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Any gender - 40-70 years old - Fasting plasma glucose <12 6mg/dL and/or hemoglobin A1c <7% - Body Mass Index (BMI) >25 kg/m2 - Elect and qualify for a water-only fast of at least 10 consecutive days - Provide informed consent Exclusion Criteria: - Active malignancy - Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's) - Stroke or heart attack within the last 90 days |
Country | Name | City | State |
---|---|---|---|
United States | TrueNorth Health Center | Santa Rosa | California |
Lead Sponsor | Collaborator |
---|---|
TrueNorth Health Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in insulin resistance from baseline | Insulin resistance assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) [fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5] | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | |
Secondary | Changes in lipid profile from baseline | Lipid profile assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) and reported in mg/dL | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | |
Secondary | Changes in weight from baseline | Weight measured on a digital scale and reported in kilograms (kg) | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | |
Secondary | Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline | SBP and DBP measured using digital blood pressure device and reported in mmHg | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | |
Secondary | Changes in abdominal circumference from baseline | Abdominal circumference measured on bare skin at the minimal waistline with a tension-sensitive, non-elastic tape and reported in centimeters (cm) | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | |
Secondary | Changes in high sensitivity C-reactive protein (hsCRP) from baseline | hsCRP assessed using serum and reported in mg/L | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast |
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