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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00339313 |
Purpose
This protocol is for study of the effect of inhibition of parasympathetic outflow on insulin secretion and glucose metabolism. Insulin secretion will be measured during infusions of escalating doses of atropine. Other clinical parameters of parasympathetic inhibition by atropine will also be assessed.
| Condition |
|---|
|
Diabetes |
| Study Type: | Observational |
| Official Title: | Food Intake and Appetite in the Children of Mothers With Diabetes |
| Estimated Enrollment: | 240 |
| Study Start Date: | January 2000 |
Children of mothers who had diabetes during pregnancy are at an increased risk of diabetes and obesity in later life, effects partly mediated by the early environment experienced by the offspring of diabetic mothers in utero. In this protocol, we address why intra-uterine exposure to maternal diabetes might lead to later childhood obesity. Previous studies of children of diabetic mothers have not detected any alteration in energy expenditure, either as resting metabolic rate or physical activity. We will now examine whether they are at an increased risk of obesity due to differences in food intake. We will assess composition of the diet, patterns of eating, taste preference and physiological responses to a mixed meal. No previous work in human subjects has addressed these issues.
Eligibility| Ages Eligible for Study: | 7 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Group 1: Offspring of mothers with diabetes during pregnancy.
Maternal diagnosis of type 2 diabetes (by WHO criteria after a 75g OGTT or on clinical grounds with at least one random plasma glucose greater than 200mg/dl) before or during the index pregnancy.
Group 2: Offspring of mothers with diabetes diagnosed following pregnancy.
Maternal diagnosis of type 2 diabetes (by WHO criteria after a 75g OGTT or on clinical grounds with at least one random plasma glucose greater than 200 mg/dl) after the index pregnancy.
It is important to also ensure that these mothers did not have any major disturbance in glucose tolerance during the index pregnancy and a record of normal glucose tolerance after the index pregnancy; therefore they will only be included if there are also:
Adequate records of glucose testing during the index pregnancy and these records are not in keeping with a diagnosis of gestational diabetes (by either WHO criteria if a 75g oral glucose tolerance test has been carried out).
At least one non-diabetic OGTT after the index pregnancy.
EXCLUSION CRITERIA:
Contacts and Locations More Information
| Study ID Numbers: | 999900005, OH00-DK-N005 |
| Study First Received: | June 19, 2006 |
| Last Updated: | October 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00339313 |
| Health Authority: | United States: Federal Government |
|
Obesity Etiology Macronutrient Selection Taste Preference Mixed Meal Test |
|
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
