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| Tracking Information | |||||||||
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| First Received Date ICMJE | October 3, 2005 | ||||||||
| Last Updated Date | May 28, 2009 | ||||||||
| Start Date ICMJE | October 2005 | ||||||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00233298 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Taste Study: A Study of the Function of Hormones Present in Taste Buds | ||||||||
| Official Title ICMJE | A Study of the Function of Hormones Present in Taste Buds | ||||||||
| Brief Summary | The purpose of this study is to find out whether the hormones in the taste buds are affected by tasting and eating food, and also whether these hormone levels are affected by an increase in body weight or type 2 diabetes. |
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| Detailed Description | This study is being done to determine whether hormones will be secreted by the taste cells located in the taste buds in response to tasting food. The study will compare responses of these hormones in participants who are healthy and normal weight, healthy and overweight, or have pre-diabetes or type 2 diabetes and overweight. Interested individuals will be scheduled for a screening visit, for which they will have to fast for at least 8 hours overnight. This visit will include medical history, physical examination, laboratory tests, and a 75-gram oral glucose tolerance test (OGTT). Participants who meet the inclusion criteria will return for seven more study visits. If the participants have type 2 diabetes and are taking oral diabetic medications, they will need to stop taking the medications 5 days (3 days if they are taking metformin) prior to the study visit. They will need to check their fasting finger-stick blood glucose using their glucose meter every morning. If the glucose value is greater than 240, they will not be eligible for the study. During the first study visit, the participants will be randomly assigned to one of seven groups:
Blood samples will be taken through an intravenous catheter every 1-minute for 40 minutes prior to the meal and then every minute for 40 minutes at the first bite of the meal. From 40 minutes to 60 minutes after the first bite, samples will be taken every 2 minutes, and from 60 to 180 minutes, samples will be taken every 15 minutes. A total of 99 blood samples will be taken. After each of the study visits, participants will be evaluated for the need for iron supplementation. The participant will return for each of the subsequent visits at least 6 weeks after the previous visit. The same procedures as described in study visit 1 will be done except for the intervention, which is randomized. A hematocrit will be done to assure that it is within normal limits. If not, iron supplement Ferrous Sulfate 325 mg orally once daily will be given to the participant, and they will be rescheduled for the next visit in 4-6 weeks. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | February 2010 | ||||||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00233298 | ||||||||
| Responsible Party | Josephine Egan, MD, Principle Investigator, National Institute of Aging | ||||||||
| Study ID Numbers ICMJE | AG0053 | ||||||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Aging (NIA) | ||||||||
| Verification Date | May 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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