Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss, Nephrology, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 7 - 21 |
| Updated: | 12/9/2017 |
| Start Date: | September 1999 |
| End Date: | September 2021 |
| Contact: | Melissa M Shaw |
| Email: | melissa.m.shaw@yale.edu |
| Phone: | 2037856459 |
The purpose of this study is to determine the prevalence of impaired glucose (carbohydrate)
tolerance in lean children with a family history of diabetes and in overweight/obese children
with or without a family history of diabetes mellitus.
tolerance in lean children with a family history of diabetes and in overweight/obese children
with or without a family history of diabetes mellitus.
The patient participates in the study for a total duration of approximately four hours. The
study nurse will do a nursing assessment, including measuring the patient's height, weight,
waist circumference, hip circumference, blood pressure, and pulse, along with evaluation of
acanthosis nigricans and striae rubrae. The patient's percent body fat, fat mass and lean
mass may also be measured using a Tanita scale. The nurse will obtain a family and medical
history from the patient and/or the patient's parent/guardian. In addition, before starting
the oral glucose tolerance test (OGTT), the nurse will request a urine sample from the
patient for analysis of microalbumin and creatinine.
The patient will receive 1.75 g/kg to a maximum of 75 g of a sugar drink, orally (Glucola).
The patient will have one intravenous line. "Emla" or a local anesthetic (0.1cc buffered
lidocaine) will be applied before the placement of the IV catheter. Blood will be drawn 10
times over three hours. Should abnormal glucose results be found, appropriate referrals will
be made. We will draw approximately 80 cc of blood during this study. The blood will be
analyzed for glucose, lactate, insulin, proinsulin, c-peptide, interleukin-6, tumor necrosis
factor-α(TNF), free fatty acids (FFAs), enhanced lipid profile, leptin, and adiponectin as
well as an optional 10 cc sample to be stored for future undetermined analysis.
study nurse will do a nursing assessment, including measuring the patient's height, weight,
waist circumference, hip circumference, blood pressure, and pulse, along with evaluation of
acanthosis nigricans and striae rubrae. The patient's percent body fat, fat mass and lean
mass may also be measured using a Tanita scale. The nurse will obtain a family and medical
history from the patient and/or the patient's parent/guardian. In addition, before starting
the oral glucose tolerance test (OGTT), the nurse will request a urine sample from the
patient for analysis of microalbumin and creatinine.
The patient will receive 1.75 g/kg to a maximum of 75 g of a sugar drink, orally (Glucola).
The patient will have one intravenous line. "Emla" or a local anesthetic (0.1cc buffered
lidocaine) will be applied before the placement of the IV catheter. Blood will be drawn 10
times over three hours. Should abnormal glucose results be found, appropriate referrals will
be made. We will draw approximately 80 cc of blood during this study. The blood will be
analyzed for glucose, lactate, insulin, proinsulin, c-peptide, interleukin-6, tumor necrosis
factor-α(TNF), free fatty acids (FFAs), enhanced lipid profile, leptin, and adiponectin as
well as an optional 10 cc sample to be stored for future undetermined analysis.
Inclusion Criteria:
- ages 7-21, family history of type 2 diabetes mellitus
Exclusion Criteria:
- Children will be excluded if they have previously been treated for another
endocrinopathy or are on any chronic medications that are known to alter glucose or
insulin metabolism, such as oral steroids, or certain psychiatric medications, such as
Xeleca, Lithium and Paxil. Lean (not overweight or obese) will be defined as a body
mass index (BMI) (kg/m2) less than the 85th percentile specific for age and gender,
overweight will be defined as a BMI between the 85th and 95th percentiles, and obesity
will be defined as a BMI greater than the 95th percentile. Children will be excluded
from participating in the genetic analysis if they are treated oral glucocorticoids or
antirejection or chemotherapy (e.g. tacrolimus, Lasparaginase.
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