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CompletedNCT00339313Updated Jul 2, 2017

Food Intake and Appetite in the Children of Mothers With Diabetes

An observational study in Diabetes, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 7 Years to 10 Years. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational

Study type
Observational
Enrollment
240
Ages
7 Years to 10 Years
Sex
All
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Diabetes

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Keywords

  • Obesity
  • Etiology
  • Macronutrient Selection
  • Taste Preference
  • Mixed Meal Test
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 240 is close to the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

EXCLUSION CRITERIA:

  1. History of weight loss for child (greater than 2kg over last 6 months).
  2. Presence of other major illnesses which might interfere with appetite or food intake in mother or child.
  3. Child not living with mother.
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Study design

Enrollment
240 participants (estimated)
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Study locations

1 site
  • NIDDK, Phoenix
    Phoenix, Arizona 85014, United States
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References and documents

Publications

  • 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. PubMed 6848933 ↗
  • Silverman 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. PubMed 8267335 ↗
  • Pettitt 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. PubMed 3360218 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00339313
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted
Jun 21, 2006
Start date
Jan 12, 2000
Completion
Jun 24, 2011
Last update
Jul 2, 2017
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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