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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 February 2013 |
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Main ID: |
NCT01200940 |
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Date of registration:
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11/09/2010 |
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Primary sponsor: |
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Public title:
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Metabolic Effects of Non-Nutritive Sweeteners
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Scientific title:
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Metabolic Effects of Non-Nutritive Sweeteners |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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250 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01200940 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) |
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Address:
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Telephone:
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800-411-1222 |
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Email:
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prpl@mail.cc.nih.gov |
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Affiliation:
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Name:
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Allison C Sylvetsky |
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Address:
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Telephone:
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(301) 435-4639 |
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Email:
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sylvetskyac@mail.nih.gov |
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Affiliation:
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Name:
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Kristina I Rother, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Key inclusion & exclusion criteria
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- MAIN STUDY:
INCLUSION CRITERIA:
- Age 18-45 years
- No known active medical conditions
EXCLUSION CRITERIA:
- Current use of prescription or non-prescription medication. Certain exceptions are
permitted, including topical medications, vitamins, and hormonal contraceptives.
Other medications may be permitted at the discretion of the investigators.
- Recent (past 2 months) use of drugs that alter glucose metabolism (e.g. metformin),
alter gastric pH (e.g. proton pump inhibitors) or gastric emptying (e.g.
metoclopramide)
- ALT or AST more than 1.5 times the upper limit of normal
- Positive urine pregnancy test
- Known allergy, sensitivity or other contraindication to any study food or drug or its
vehicle
- Psychiatric or cognitive disorder that will, in the opinion of the investigators,
limit the subject's ability to provide informed consent, or to comply with study
procedures
- Body weight less than 50 kg
- Abnormal glucose tolerance (fasting blood glucose of 100 mg/dl or higher, or 2-hour
blood glucose of 140 or higher on oral glucose tolerance testing)
- Glycosuria
PEDIATRIC PILOT STUDY:
INCLUSION CRITERIA:
- Age 6-12 years at enrollment
- Body weight at least 17 kg
- Prepubertal (Tanner stage I breasts in girls, or testicular volumes less than or
equal to 3 mL in boys)
- No known active medical conditions
EXCLUSION CRITERIA:
- Current use of prescription or non-prescription medication. Certain exceptions are
permitted, including topical medications and vitamins. Other medications may be
permitted at the discretion of the investigators.
- Recent (past 2 months) use of drugs that alter glucose metabolism (e.g. metformin),
alter gastric pH (e.g. proton pump inhibitors) or gastric emptying (e.g.
metoclopramide)
- ALT or AST more than 1.5 times the upper limit of normal
- Known allergy, sensitivity or other contraindication to any study food or drug or its
vehicle
- Psychiatric or cognitive disorder that will, in the opinion of the investigators,
limit the subject's ability to provide assent, and/or the subject's parent/guardian
to provide informed consent, or to comply with study procedures
- Abnormal glucose tolerance (fasting blood glucose of 100 mg/dl or higher, or 2-hour
blood glucose of 140 or higher on oral glucose tolerance testing)
- Glycosuria
Age minimum:
6 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Other: Sucralose
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Primary Outcome(s)
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The primary aim of this study is to confirm that the non-nutritive sweetener sucralose (versus other ingredients in diet soda) augments glucose-stimulated GLP-1 secretion.
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Secondary Outcome(s)
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-A secondary aim of this study is to study whether increased GLP-1 secretion due to non-nutritive sweeteners alters gastric emptying or satiety.-An additional aim of this study is to determine a dose-response relationship for non-nutritive...
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Secondary ID(s)
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10-DK-0163
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100163
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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