NCT00339313

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2000

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2011

Completed
Last Updated

July 2, 2017

Status Verified

June 24, 2011

First QC Date

June 19, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

ObesityEtiologyMacronutrient SelectionTaste PreferenceMixed Meal Test

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

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: 6848933BACKGROUND
  • 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.

    PMID: 8267335BACKGROUND
  • 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.

    PMID: 3360218BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations