Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-02-29
2023-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Fasting (Healthy)
Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to10 different sweet beverages, separated by 2 weeks.
oral carbohydrate challenge
Participants will fast for 8 hours and then drink a beverage containing fructose.
Fasting (metabolic syndrome)
Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to10 different sweet beverages, separated by 2 weeks.
oral carbohydrate challenge
Participants will fast for 8 hours and then drink a beverage containing fructose.
Interventions
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oral carbohydrate challenge
Participants will fast for 8 hours and then drink a beverage containing fructose.
Eligibility Criteria
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Inclusion Criteria
* 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
* Ability to follow verbal and written instructions in English
* Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
3 or more of the following (based on joint scientific statement by Alberti et al, 2009:
* Fasting triglycerides \>150 mg/dl (or on treatment for elevated triglycerides)
* HDL cholesterol \<40 mg/dl in men or \<50 mg/dl in women
* Blood pressure \> 130/85 (or antihypertensive treatment in a subject with history of hypertension)
* Fasting BG \>100
* Elevated waist circumference \*\* see below for race and ethnic specifications
Men Women
* Asian or Central, South or Native American \> 90 cm \> 80 cm
* Non-Asian, Non-Latino United States \> 102 cm \> 88 cm
Exclusion Criteria
* 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)
* Marijuana or 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
18 Years
60 Years
ALL
Yes
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Jody Dushay
Assistant Professor of Medicine
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2015P000381
Identifier Type: -
Identifier Source: org_study_id
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