Overweight24HrNCT02011581
Diurnal Variability in the Regulation of Beta-cell Function and Insulin Sensitivity in Overweight People
An observational study of Overweight, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Females
- 18-55 years old
- BMI between 25.0-29.9 kg/m2
- Must be sedentary (regular exercise <1hour/week or <2 times/week
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Overweight
- Keywords
- Overweight
- Medical subject headings
- Overweight
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 hours
Secondary outcomes (3)
Determine whether there is diurnal variability in muscle insulin signaling
This muscle samples will be obtained two times (every 12 hours for 24 hours)to assess NAMPT and NAD+ concentrations, SIRT1 activity, and factors involved in insulin signaling.
Measured: 24 hours
Determine whether there is diurnal variability in adipose tissue and systemic inflammation.
Subcutaneous adipose tissue samples will be obtained four times (every 6 hours for 24 hours) to evaluate NAMPT and NAD+ concentrations, SIRT1 activity, and markers of inflammation.
Measured: 24 hours
Determine whether there is diurnal variability in NAMPT-mediated NAD+ biosynthesis and SIRT1.
Blood samples will be obtained at regular intervals for 24 hours to evaluate; 1)plasma free fatty acids (FFA), glucose and insulin concentrations, 2)NAMPT and NAD+ concentrations, 3)SIRT1 activity,and 4)systemic markers of inflammation (C-reactive protein and interleukin (IL) -6).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011581
- Sponsor's protocol ID
- 2011-09110
- Acronym
- 24Hr
- Status last verified
- Apr 2015
- First submitted
- 9 Dec 2013
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29294006
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diurnal Variability in the Regulation of Beta-cell Function and Insulin Sensitivity in Overweight People
- ClinicalTrials.gov ID
- NCT02011581
- Acronym / sponsor ID
- 24Hr / 2011-09110
- Conditions
- Overweight
- Keywords
- Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Females
- 18-55 years old
- BMI between 25.0-29.9 kg/m2
- Must be sedentary (regular exercise <1hour/week or <2 times/week
Key exclusion criteria (8 listed)
- Regular exercise (>1hour/week or >2 times/week)
- Diabetes
- Severe organ dysfunction
- Smokers
- Severe hypertriglyceridemia (>300 mg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine postprandial beta-cell function (insulin secretion) after ingesting breakfast and dinner meals.
Time frame: 24 hours
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.
Determine postprandial hepatic insulin sensitivity (suppression of endogenous glucose production) after ingesting breakfast and dinner meals.
Time frame: 24 hours
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.
3 secondary outcomes
Determine whether there is diurnal variability in muscle insulin signaling
Time frame: 24 hours
Determine whether there is diurnal variability in adipose tissue and systemic inflammation.
Time frame: 24 hours
Determine whether there is diurnal variability in NAMPT-mediated NAD+ biosynthesis and SIRT1.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Derived from this study: PubMed 29294006Yamaguchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Klein, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine postprandial beta-cell function (insulin secretion) after ingesting breakfast and dinner meals. (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02011581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.