Obesity1651NCT00795275
Incretin Effect in People With Impaired Fasting Glucose
A study testing Sitagliptin Phosphate in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Sitagliptin Phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Nov 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, sedentary, non-smokers, men and women 45-70 years old Subjects were placed into 1 of the 2 groups based on two 2-hour 75g oral glucose tolerance tests (2h OGTT), separated by one week: a control group with normal glucose tolerance (NGT; n=14; fasting glucose <5.6 mmol/l and 2h OGTT <7.8 mmol/l), or IFG (n=10; fasting glucose 5.6-6.9 mmol/l, and 2h OGTT <7.8 mmol/l).
Who cannot join
- Subjects were excluded for: thyroid stimulating hormone <50 or >500 milliunits/L, fasting triglycerides >10.3 mmol/l, creatinine >130 μmol/l, elevated liver function tests (>2 times normal), hematocrit < 38%, or white blood cell count <3.0 x 103. Use of medications for lipid and/or glucose lowering also excluded enrollees. Women may not have used hormone replacement therapy in the past 1 year. Smokers. BMI <25 or >40 kg/m2. Diabetes or impaired glucose tolerance.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Exploring the Incretin Effect in People With IFG
Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. The investigators hypothesized that defects in GLP-1 may explain the inappropriate basal EGP and diminished insulin secretion in IFG, and, furthermore, that by increasing circulating GLP-1 levels (using a new medicine called "sitagliptin") the investigators could reverse these defects.
- Conditions
- Obesity
- Being tested
- Sitagliptin Phosphate
- Keywords
- pre-diabetes, isotopes, insulin secretion, insulin action, GLP-1, simple obesity, impaired fasting glucose
- Medical subject headings
- Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin PhosphateDrug
Also called brand name: Januvia
Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
| Study group | Role | What they receive |
|---|---|---|
| Impaired Fasting Glucose | Experimental | Treatment of people with impaired fasting glucose with Januvia (sitagliptin phosphate) Receives: Drug: Sitagliptin Phosphate |
| Normal glucose tolerance | Experimental | Treatment of people with normal glucose tolerance with Januvia (sitagliptin phosphate) Receives: Drug: Sitagliptin Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endogenous Glucose Production
Measured: Baseline and 28 days
Change in Insulin Secretion
Measured: Baseline and 28 days
Secondary outcomes (7)
Insulin Secretion in Response to Oral vs. IV Glucose
Measured: Baseline
Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide
Measured: Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon
Measured: Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1
Measured: Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: Lactate
Measured: Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: FFA
Measured: Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol
Measured: Baseline and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Perreault, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795275
- Sponsor's protocol ID
- 07-0749
- Acronym
- 1651
- Status last verified
- Mar 2021
- First submitted
- 20 Nov 2008
- Last updated
- 5 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Perreault L, Man CD, Hunerdosse DM, Cobelli C, Bergman BC. Incretin action maintains insulin secretion, but not hepatic insulin action, in people with impaired fasting glucose. Diabetes Res Clin Pract. 2010 Oct;90(1):87-94. doi: 10.1016/j.diabres.2010.06.012. Epub 2010 Aug 13.
PubMed 20708814
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Incretin Effect in People With IFG
- ClinicalTrials.gov ID
- NCT00795275
- Acronym / sponsor ID
- 1651 / 07-0749
- Conditions
- Obesity
- Keywords
- pre-diabetes, isotopes, insulin secretion, insulin action, GLP-1, simple obesity, impaired fasting glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Posted 5 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. The investigators hypothesized that defects in GLP-1 may explain the inappropriate basal EGP and diminished insulin secretion in IFG, and, furthermore, that by increasing circulating GLP-1 levels (using a new medicine called "sitagliptin") the investigators could reverse these defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impaired Fasting Glucose | Experimental | Drug: Sitagliptin PhosphateTreatment of people with impaired fasting glucose with Januvia (sitagliptin phosphate) |
| Normal glucose tolerance | Experimental | Drug: Sitagliptin PhosphateTreatment of people with normal glucose tolerance with Januvia (sitagliptin phosphate) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, sedentary, non-smokers, men and women 45-70 years old Subjects were placed into 1 of the 2 groups based on two 2-hour 75g oral glucose tolerance tests (2h OGTT), separated by one week: a control group with normal glucose tolerance (NGT; n=14; fasting glucose <5.6 mmol/l and 2h OGTT <7.8 mmol/l), or IFG (n=10; fasting glucose 5.6-6.9 mmol/l, and 2h OGTT <7.8 mmol/l).
Key exclusion criteria (1 listed)
- Subjects were excluded for: thyroid stimulating hormone <50 or >500 milliunits/L, fasting triglycerides >10.3 mmol/l, creatinine >130 μmol/l, elevated liver function tests (>2 times normal), hematocrit < 38%, or white blood cell count <3.0 x 103. Use of medications for lipid and/or glucose lowering also excluded enrollees. Women may not have used hormone replacement therapy in the past 1 year. Smokers. BMI <25 or >40 kg/m2. Diabetes or impaired glucose tolerance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitagliptin PhosphateAlso: brand name: JanuviaJanuvia 100 mg po qd x 28 days for all subjects after baseline measures made | Drug | Impaired Fasting Glucose, Normal glucose tolerance |
Primary outcome
Change in Endogenous Glucose Production
Time frame: Baseline and 28 days
Change in Insulin Secretion
Time frame: Baseline and 28 days
7 secondary outcomes
Insulin Secretion in Response to Oral vs. IV Glucose
Time frame: Baseline
Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide
Time frame: Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon
Time frame: Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1
Time frame: Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: Lactate
Time frame: Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: FFA
Time frame: Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol
Time frame: Baseline and 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20708814Perreault L, Man CD, Hunerdosse DM, Cobelli C, Bergman BC. Incretin action maintains insulin secretion, but not hepatic insulin action, in people with impaired fasting glucose. Diabetes Res Clin Pract. 2010 Oct;90(1):87-94. doi: 10.1016/j.diabres.2010.06.012. Epub 2010 Aug 13.
- Individual participant dataSharing planned: No
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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.
Leigh Perreault, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitagliptin Phosphate in people with Obesity, run by University of Colorado, Denver 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 1 inclusion and 1 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 5 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Endogenous Glucose Production (time frame: Baseline and 28 days). 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 NCT00795275, 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 5 Apr 2021.