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Diurnal Variability in the Regulation of Beta-cell Function and Insulin Sensitivity in Overweight People

NCT ID: NCT02011581

Last Updated: 2015-04-30

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

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-03-31

Brief Summary

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The purpose of this research study is to learn more about how our body produces sugar, breaks down fat for fuel, and makes insulin (the major hormone that controls the production of blood sugar and fat breakdown) during a 24-hour day and how body fat and muscle are involved in these processes.

Detailed Description

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The purpose of this study is to determine whether there are diurnal differences in postprandial beta-cell function and hepatic insulin sensitivity and the factors that influence these metabolic functions, including insulin signaling, adipose tissue and systemic inflammation, nicotinamide phosphoribosyltransferase (NAMPT)-mediated nicotinamide adenine dinucleotide(NAD) biosynthesis, and sirtuin (silent mating type information regulation 2 homolog 1 (SIRT1)) in overweight human subjects.

Conditions

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Overweight

Keywords

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Overweight

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Females
* 18-55 years old
* BMI between 25.0-29.9 kg/m2
* Must be sedentary (regular exercise \<1hour/week or \<2 times/week

Exclusion Criteria

* Regular exercise (\>1hour/week or \>2 times/week)
* Diabetes
* Severe organ dysfunction
* Smokers
* Severe hypertriglyceridemia (\>300 mg/dl)
* Medications that may alter the results of the study
* Pregnant
* Breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Klein, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Yamaguchi S, Moseley AC, Almeda-Valdes P, Stromsdorfer KL, Franczyk MP, Okunade AL, Patterson BW, Klein S, Yoshino J. Diurnal Variation in PDK4 Expression Is Associated With Plasma Free Fatty Acid Availability in People. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1068-1076. doi: 10.1210/jc.2017-02230.

Reference Type DERIVED
PMID: 29294006 (View on PubMed)

Other Identifiers

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2011-09110

Identifier Type: -

Identifier Source: org_study_id