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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TERMINATED
NA
12 participants
INTERVENTIONAL
2016-10-31
2018-11-30
Brief Summary
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Detailed Description
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The glycemic index is defined as the "incremental area under the glucose response curve after standard amount of carbohydrate relative to that of a control food (white bread or glucose) is consumed." In general, the glycemic index quantifies the relative effect of the carbohydrate content of the food on resultant blood glucose.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Glucose100
Participants in this arm will randomly receive 100% glucose in the OGTT drink 3 out of 9 visits.
Glucose100
Oral Glucose Tolerance Test
For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes. Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink. Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.
Glucose50
Participants in this arm will randomly receive 50% glucose in the OGTT drink 3 out of 9 visits.
Glucose50
Oral Glucose Tolerance Test
For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes. Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink. Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.
Glucose42
Participants in this arm will randomly receive 42% glucose in the OGTT drink 3 out of 9 visits.
Glucose42
Oral Glucose Tolerance Test
For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes. Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink. Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.
Interventions
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Glucose100
Glucose50
Glucose42
Oral Glucose Tolerance Test
For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes. Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink. Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* no medications
* no weight changes over the previous 6 months (defined as \>=10% change in body weight)
Exclusion Criteria
* prior bariatric surgery
* significant medical condition such as cardiac or pulmonary disease, coagulopathy, gastrointestinal disorder, or known history of Type 1 or Type 2 diabetes
* women who are pregnant or lactating
* medications (except for oral contraceptives, thyroxins, drugs for hypertension, drugs for osteoporosis, or vitamins and minerals)
* no major medical or surgical event requiring hospitalization in the past 3 months
* no disease or drugs that influence digestion
18 Years
45 Years
ALL
Yes
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Eugene Shapiro, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Ania M Jastreboff, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Robert S Sherwin, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale Center for Clinical Investigation Church Street Research Unit
New Haven, Connecticut, United States
Countries
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References
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Ludwig DS. The glycemic index: physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. JAMA. 2002 May 8;287(18):2414-23. doi: 10.1001/jama.287.18.2414.
Other Identifiers
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1604017520
Identifier Type: -
Identifier Source: org_study_id
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