Insulin Resistance
Conditions
Brief summary
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.
Detailed description
Ischemic stroke is a leading cause of death and a major public health burden. Data suggests that insulin resistance is a potential risk factor for cardiovascular disease, including ischemic stroke, and that dietary and lifestyle intervention can reduce insulin resistance as well as these disease risks. Nonetheless, current intervention strategies have done little to reduce overall stroke incidence. Therefore, an intervention, such as prolonged medically supervised water-only fasting, might be an effective strategy to both reduce insulin resistance and encourage dietary and lifestyle changes that reduce incidence of stroke. 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. Additionally, the study will assess if markers of cardiovascular health and inflammation change before and after water-only fasting. Water-only fasting participants will be recruited from patients who voluntarily elect to water-only fast for 10 or more consecutive days. Clinical variables and blood will be collected at baseline, every 7th day during fasting and refeeding, and the final day of fasting and refeeding.
Interventions
OTHERWater-only Fasting
Water-only fasting for at least 10 days followed by 5 days of refeed.
Sponsors
TrueNorth Health Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in insulin resistance from baseline | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | Insulin resistance assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) \[fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in lipid profile from baseline | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | Lipid profile assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) and reported in mg/dL |
| Changes in weight from baseline | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | Weight measured on a digital scale and reported in kilograms (kg) |
| Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | SBP and DBP measured using digital blood pressure device and reported in mmHg |
| Changes in abdominal circumference from baseline | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | Abdominal circumference measured on bare skin at the minimal waistline with a tension-sensitive, non-elastic tape and reported in centimeters (cm) |
| Changes in high sensitivity C-reactive protein (hsCRP) from baseline | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | hsCRP assessed using serum and reported in mg/L |
Countries
United States
Outcome results
None listed