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| Name | Class |
|---|---|
| Intermountain Research and Medical Foundation | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| water-only 24-hour fasting once per week for 6 weeks | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| water-only 24-hour fasting once per week for 6 weeks | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Weight Between Baseline and the End of the Sixth Week | 6 weeks | |
| Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week. | 6 weeks | |
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Inclusion Criteria:
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:
Evidence of metabolic syndrome by having at least 3 of the following 5 criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin D Horne, PhD, MPH | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84107 | United States | ||
| Intermountain Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Water-only 24-hour Fasting Once Per Week for 6 Weeks | water-only 24-hour fasting once per week for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Water-only 24-hour Fasting Once Per Week for 6 Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week. | Posted | Mean | Standard Deviation | mg/dL | 6 weeks |
|
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Water-only 24-hour Fasting Once Per Week for 6 Weeks | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin D. Horne | Intermountain Heart Institute | 8015074708 | benjamin.horne@imail.org |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D008659 | Metabolic Diseases |
| D005215 | Fasting |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005247 | Feeding Behavior |
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| Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week. |
| 6 weeks |
| Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week. | 6 weeks |
| Salt Lake City |
| Utah |
| 84107 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Difference in Weight Between Baseline and the End of the Sixth Week | Posted | Mean | Standard Deviation | kg | 6 weeks |
|
|
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| Secondary | Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week. | Posted | Mean | Standard Deviation | mg/dL | 6 weeks |
|
|
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| Secondary | Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week. | Posted | Mean | Standard Deviation | ng/mL | 6 weeks |
|
|
|
| Secondary | Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week. | Posted | Mean | Standard Deviation | trillion cells/L | 6 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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| D001519 | Behavior |
| D006943 | Hyperglycemia |