Status:
COMPLETED
A Study of the Function of Hormones Present In Taste Buds
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Diabetes
Obesity
Eligibility:
All Genders
12-50 years
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 weigh...
Detailed Description
Cephalic phase of insulin secretion is regulated by autonomic and endocrine responses to food-related sensory stimulation such as sight, smell, and taste. Human taste perception comprises of at least ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Males or females age 20 to 50
- body weight \> 50 kg (110 pounds)
- Group A
- BMI \< 25 kg/m(2)
- healthy
- Group B
- BMI greater than or equal to 30 kg/ m(2)
- healthy
- Group C
- Pre-diabetes
- Pre-diabetes is defined as having either impaired fasting glucose (IFG) (fasting plasma glucose (FPG) greater than or equal to100 mg/dl but \< 126 mg/dl) and/or impaired glucose tolerance (IGT) (2-hour OGTT glucose greater than or equal to140 mg/dl but \< 200 mg/dl).
- BMI greater than or equal to 30 kg/m(2)
- Group D
- Type 2 diabetes (on diet or oral agents management only except for thiazolidinediones)
- Type 2 diabetes is defined as FPG 126 mg/dl and/or 2-hour OGTT glucose
- 200
- BMI greater than or equal to 30 kg/m(2)
- Screening laboratory evaluations with no significant abnormal results:
- comprehensive metabolic panel
- complete blood count with differential and platelets
- fasting plasma glucose \< 100 mg/dl for healthy groups only (Group A and B)
- 2-hour 75-gram OGTT glucose \< 140 mg/dl for healthy groups only (Group A and B)
- Negative pregnancy test for women of child-bearing potential
- Able to complete an informed consent
- EXCLUSION CRITERIA:
- Pregnancy (pregnancy has been shown to be associated with decrease in insulin sensitivity
- Group A and B subjects cannot have FPG greater than or equal to 100 mg/dl or 2-hr OGTT greater than or equal to 140 mg/dl
- Group D subjects cannot have FPG \> 240 mg/dl during the screening visit
- Group D subjects cannot have their morning fasting finger-stick glucose \> 240 mg/dl during the 5 days (3 days for glucophage) prior to the visit when their oral hypoglycemic agent(s) are discontinued
- Subjects with type 2 diabetes on insulin therapy
- Hematocrit \< 36% for women and \< 38% for men
- Peanut allergy
- Presence of other medical conditions that could affect glucose homeostasis
- Use of medications known to impair glucose homeostasis (i.e., amiloride shown to inhibit certain taste responses in hamsters)
- History of liver or renal disease
- History of gastrointestinal or endocrine disorders except for treated hypo- or hyperthyroidism
- Long-term glucocorticoid use (over one month), or other immunosuppressive agents within the past 5 years
Exclusion
Key Trial Info
Start Date :
May 26 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 2 2015
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00233298
Start Date
May 26 2005
End Date
January 2 2015
Last Update
April 5 2018
Active Locations (1)
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1
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224