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

NCT ID: NCT00720889

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Insulin Resistance Type 2 Diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

short sleep duration glucose clamp technique insulin secretion insulin action lipid turnover free fatty acids

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Plamen D Penev, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Chicago

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HL089637

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16079A-S2

Identifier Type: -

Identifier Source: org_study_id