Fasting Clinical Trial
— E228Official title:
The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans
NCT number | NCT03201549 |
Other study ID # | 2017P000053 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 30, 2017 |
Est. completion date | June 30, 2023 |
Verified date | August 2023 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Ages 18-60 - BMI 19-25 kg/m2; 19-23 for Asian subjects - Stable weight (variation < 3 kg within 6 months of screening visit) - Ability to give informed consent in English - Use of medically approved form of contraception Exclusion Criteria: - Fasting blood glucose >100 - Hemoglobin A1C% > 6.5% - Fasting triglycerides >150 - Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria - Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure) - Uncontrolled hypertension (BP > 160/100 mmHg on or off antihypertensive medication) intravenous drug use - Recent weight loss (> 3 kg within 6 months of the screening visit) - Gastroparesis - Inflammatory or irritable bowel disease - Malignancy treated with chemotherapy within the past 3 years - Depression or psychosis requiring hospitalization - Renal insufficiency (creatinine clearance < 40 ml/min) - Transaminases > 2x above the normal range - Known liver disease - Pregnancy within 6 months of the screening visit - Lactation - Failure to use medically approved contraceptive methods - History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling) - Change in dose of thyroid hormone or antithyroidal medication within 3 months of screening visit - History of alcohol abuse within the past 5 years - Fructose intolerance Exclusionary medications: - Oral steroids - Metformin - Weight loss medications including nonprescription supplements |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum FGF21 levels | 2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
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