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

NCT02011581 | Completed DMC

• 1 other identifier: 2011-09110
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Keywords

Overweight

Outcome Measures

Primary Outcomes (2)

• Determine postprandial beta-cell function (insulin secretion) after ingesting breakfast and dinner meals.

  Postprandial pancreatic beta-cell function will be evaluated by using a mixed meal labelled with stable isotope tracers, in conjunction with stable isotope tracer infusion. Metabolic outcomes from the breakfast meal will be compared with values obtained after dinner.

  24 hours

• Determine postprandial hepatic insulin sensitivity (suppression of endogenous glucose production) after ingesting breakfast and dinner meals.

  Postprandial pancreatic hepatic insulin sensitivity will be evaluated by using a mixed meal labelled with stable isotope tracers, in conjunction with stable isotope tracer infusion. Metabolic outcomes from the breakfast meal will be compared with values obtained after dinner.

  24 hours

Secondary Outcomes (3)

• Determine whether there is diurnal variability in muscle insulin signaling

  24 hours

• Determine whether there is diurnal variability in adipose tissue and systemic inflammation.

  24 hours

• Determine whether there is diurnal variability in NAMPT-mediated NAD+ biosynthesis and SIRT1.

  24 hours

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 29294006 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, adipose tissue samples and muscle samples

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Klein, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 13, 2013
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

US (1)