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

September 4, 2013 updated by: University of Chicago

Sleep, Energy Metabolism and Diabetes Risk.

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy non-obese community-living men and women with a parent, sibling or grandparent who has type 2 diabetes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Reduced sleep
Habitual sleep duration of less than 6 hours per night on most days of the week and total sleep of less than 43 hours per week.
Reference sleep
Habitual sleep duration between 7 and 8.5 hours per night on most days of the week and total sleep of at least 53 hours per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total body insulin sensitivity
Time Frame: at the end of a 4-hour hyperinsulinemic clamp
at the end of a 4-hour hyperinsulinemic clamp

Secondary Outcome Measures

Outcome Measure
Time Frame
First and second phase insulin secretion
Time Frame: during a 3-hour hyperglycemic clamp
during a 3-hour hyperglycemic clamp
Endogenous glucose production
Time Frame: before and during a 4-hour hyperinsulinemic clamp
before and during a 4-hour hyperinsulinemic clamp
Glycerol turnover and free fatty acid concentration
Time Frame: before and during a 4-hour hyperinsulinemic clamp
before and during a 4-hour hyperinsulinemic clamp

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Plamen D Penev, MD, PhD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 21, 2008

First Submitted That Met QC Criteria

July 21, 2008

First Posted (Estimate)

July 23, 2008

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16079A-S2
  • R01HL089637 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe