Glucose Metabolism and Sleep in People With Family History of Type 2 Diabetes.

Type 2 Diabetes Clinical Trial

Official title:

Sleep, Energy Metabolism and Diabetes Risk.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720889
• Other study ID #: 16079A-S2
• Secondary ID: R01HL089637
• Status: Completed
• Phase: N/A
• First received: July 21, 2008
• Last updated: September 4, 2013
• Start date: July 2008
• Est. completion date: March 2012

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the carbohydrate metabolism of people who have a relative with type 2 diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis that individual differences in habitual sleep duration may be related to differences in the carbohydrate metabolism of people who have a history of type 2 diabetes in their family.

Description:

On two consecutive inpatient days, the participants in this study will undergo two different tests. The first test will determine how much insulin can their body produce in response to an intravenous glucose infusion over a period of several hours. The second test will determine how effective is the action of the sugar-processing hormone, insulin, in their body when it is infused intravenously together with glucose over a period of several hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• regular sleep habits

• BMI 20 to 27 kg/m2

• at least one parent, sibling or grandparent with type 2 diabetes

• no regular exercise habits

Exclusion Criteria:

• active smoker

• night or shift work

• have highly variable sleep habits

• have a hormonal disorder

• have a sleep disorder

• have an active medical problem

• women only: use of birth control pills

• women only: irregular menstrual periods or pregnancy

• use of medications/compounds that can disrupt sleep

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Sleep
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total body insulin sensitivity		at the end of a 4-hour hyperinsulinemic clamp	No
Secondary	First and second phase insulin secretion		during a 3-hour hyperglycemic clamp	No
Secondary	Endogenous glucose production		before and during a 4-hour hyperinsulinemic clamp	No
Secondary	Glycerol turnover and free fatty acid concentration		before and during a 4-hour hyperinsulinemic clamp	No