Food Intake and Appetite in the Children of Mothers With Diabetes
2 other identifiers
observational
240
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2000
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2000
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2011
CompletedJuly 2, 2017
June 24, 2011
June 19, 2006
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of weight loss for child (greater than 2kg over last 6 months).
- Presence of other major illnesses which might interfere with appetite or food intake in mother or child.
- Child not living with mother.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NIDDK, Phoenix
Phoenix, Arizona, 85014, United States
Related Publications (3)
Pettitt DJ, Baird HR, Aleck KA, Bennett PH, Knowler WC. Excessive obesity in offspring of Pima Indian women with diabetes during pregnancy. N Engl J Med. 1983 Feb 3;308(5):242-5. doi: 10.1056/NEJM198302033080502.
PMID: 6848933BACKGROUNDSilverman BL, Landsberg L, Metzger BE. Fetal hyperinsulinism in offspring of diabetic mothers. Association with the subsequent development of childhood obesity. Ann N Y Acad Sci. 1993 Oct 29;699:36-45. doi: 10.1111/j.1749-6632.1993.tb18835.x. No abstract available.
PMID: 8267335BACKGROUNDPettitt DJ, Aleck KA, Baird HR, Carraher MJ, Bennett PH, Knowler WC. Congenital susceptibility to NIDDM. Role of intrauterine environment. Diabetes. 1988 May;37(5):622-8. doi: 10.2337/diab.37.5.622.
PMID: 3360218BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
January 12, 2000
Study Completion
June 24, 2011
Last Updated
July 2, 2017
Record last verified: 2011-06-24