Clinical trial NCT02011581: Diurnal Variability in the Regulation of Beta-cell Function and Insulin Sensitivity in Overweight People
Official title: Diurnal Variability in the Regulation of Beta-cell Function and Insulin Sensitivity in Overweight People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Keywords: Overweight
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of female subjects of all races and ethnic groups. Participants will be recruited by reviewing our database of research subjects containing thousands of research study volunteers and by St. Louis metro area postings.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine postprandial beta-cell function (insulin secretion) after ingesting breakfast and dinner meals.
timeFrame: 24 hours
measure: Determine postprandial hepatic insulin sensitivity (suppression of endogenous glucose production) after ingesting breakfast and dinner meals.
timeFrame: 24 hours
Secondary outcomes:
measure: Determine whether there is diurnal variability in muscle insulin signaling
timeFrame: 24 hours
measure: Determine whether there is diurnal variability in adipose tissue and systemic inflammation.
timeFrame: 24 hours
measure: Determine whether there is diurnal variability in NAMPT-mediated NAD+ biosynthesis and SIRT1.
timeFrame: 24 hours
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Samuel Klein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.