ObesityPhase 4NCT01701973

Effect of DPP4 Inhibition on Growth Hormone Secretion

A Phase 4 study testing Sitagliptin, Pegvisomant and L-NMMA in people with Obesity, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study tests the following hypotheses: Aim 1: Test the hypothesis that acute dipeptidyl peptidase 4 (DPP4) inhibition with the currently available anti-diabetic drug, sitagliptin, will increase stimulated growth hormone (GH) secretion in healthy lean adults by decreasing the degradation of growth hormone releasing… Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Sitagliptin, Pegvisomant and L-NMMA
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Jan 2013to May 2017
Phase: Phase 4
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 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 18 to 40 years inclusive
BMI ≤ 25 kg/m2
For female subjects:
Status-post surgical sterilization, or If of child-bearing potential, utilization of a barrier method of birth control following negative serum pregnancy test at screening visit and on every study day

Who cannot join

Smoking
Type 1 or Type 2 Diabetes Mellitus, as defined by a fasting glucose of 126 mg/dL or greater at the time of screening visit or the use of anti-diabetic medication
Hypertension, as defined by an untreated seated systolic blood pressure (SBP) greater than 140 mmHg and/or an untreated diastolic blood pressure (DBP) greater than 90 mmHg at the time of screening visit or the use of anti-hypertensive medication
History of reported or recorded hypoglycemia (plasma glucose < 70 mg/dL)
Pregnancy and/or Breast-Feeding
Use of any medication other than multivitamin, including use of transdermal as well as oral hormone replacement therapy or use of oral contraceptive therapy

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Anemia defined as hematocrit <35% at screening visit
Cardiovascular or cerebrovascular disease, including history of myocardial infarction, history of congestive heart failure, history of stroke
Pulmonary Hypertension
Abnormal thyroid hormone levels (TSH) at the time of screening visit
Abnormal serum insulin like growth factor-1 (IGF-1) at the time of screening visit
Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m^2
Impaired hepatic function (alanine or aspartate transaminase > 2 X upper limit of normal range)
Treatment with an investigational drug in the 1 month preceding the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: The Effect of Dipeptidyl Peptidase IV Inhibition on Growth Hormone-Mediated Vasodilation

This study tests the following hypotheses:

Aim 1: Test the hypothesis that acute dipeptidyl peptidase 4 (DPP4) inhibition with the currently available anti-diabetic drug, sitagliptin, will increase stimulated growth hormone (GH) secretion in healthy lean adults by decreasing the degradation of growth hormone releasing hormone (GHRH).

Aim 2: Test the hypothesis that decreased degradation of GHRH during acute DPP4 inhibition will result in an increase in endothelium-dependent vasodilation mediated by GH and independent from GLP1 (glucagon like peptide-1) in healthy lean adults.

This study promises to provide novel data regarding how this increasingly used class of anti-diabetic drugs affects the pituitary GH axis and could affect blood vessel relaxation. Growth hormone levels are low in the setting of obesity and pre-diabetes. A further study may evaluate the effect of chronic DPP4 inhibitor therapy in a population of patients with obesity and pre-diabetes.

Read the detailed description

Growth hormone secretion is low in patients with obesity, insulin resistance, and hyperlipidemia. GH therapy in these populations and others has been limited by side effects which include hyperglycemia. Another strategy to increase GH secretion is to enhance pulsatile GH secretion by growth hormone releasing hormone. Growth hormone releasing hormone (GHRH) has a half life of 5 minutes due to its rapid inactivation by DPP4. An alternative strategy to increase endogenous GH secretion is by inhibiting degradation of GHRH by DPP4. DPP4 inhibitors are currently approved therapies for the treatment of hyperglycemia in patients with type 2 diabetes mellitus. They additionally cause blood vessel relaxation. We therefore propose to test the hypothesis that DPP4 inhibition simultaneously enhances GH secretion while improving blood glucoses and vascular function in patient populations with low GH and increased cardiovascular risk. These preliminary aims serve primarily as a novel "proof of concept" study to define the effect of acute pharmacologic DPPIV inhibition on stimulated GH secretion.

Conditions: Obesity
Being tested: Sitagliptin, Pegvisomant, Placebo, L-NMMA, Exendin 9-39
Keywords: obesity, growth hormone
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SitagliptinDrug
Also called Januvia
During Aim 1, given on one of two study days (other study day subjects receive placebo.) During Aim 2, given during both of two study days.
PegvisomantDrug
Also called Somavert
During Aim 2, given 72 hours prior to one of two study days (Group B subjects only)
PlaceboDrug
Also called sugar pill
During Aim 1, given on one of two study days (other study day subjects receive sitagliptin.) During Aim 2, given on one of two study days (other study day subjects receive either L-NMMA, pegvisomant, or Exendin 9-39 pending their group assignment)
L-NMMADrug
Also called L-N-Monomethyl-arginine
During Aim 2, given during one of two study days (Group A subjects only)
Exendin 9-39Drug
During Aim 2, given during one of two study days (Group C subjects only)

Study groups in NCT01701973
Study group	Role	What they receive
Group A (14 healthy subjects)	Other	In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo. In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either LNMMA (L-N-Monomethyl-arginine) versus placebo. Receives: Drug: Sitagliptin; Drug: Placebo; Drug: L-NMMA
Group B (14 healthy subjects)	Other	In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo. In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either pegvisomant versus placebo. Receives: Drug: Sitagliptin; Drug: Pegvisomant; Drug: Placebo
Group C (14 healthy subjects)	Other	In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo. In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either Exendin 9-39 versus placebo. Receives: Drug: Sitagliptin; Drug: Placebo; Drug: Exendin 9-39

What is being measured

The primary outcome is the main question the study is designed to answer.

Aim 1: Stimulated Peak Growth Hormone Level
Subjects underwent two study days separated by a washout period. On one study day they will receive sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine (30 grams i.v. over 30 minutes) on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
Measured: Growth Hormone Level at 30 minutes (i.e. at completion of arginine infusion), 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Aim 1: Percent Change From Baseline in Forearm Vascular Resistance
Forearm blood flow was determined by strain gauge plethysmography. Forearm vascular resistance was then calculated by dividing this into mean arterial pressure. The percent change from baseline was determined at each timepoint.
Measured: Percent change from baseline in forearm vascular resistance at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Aim 1: Percent Change From Baseline in Forearm Blood Flow
Forearm blood flow was determined by strain gauge plethysmography. The percent change from baseline was determined at each timepoint.
Measured: Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.
Aim 2: Percent Change From Baseline in Forearm Blood Flow
Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus another study drug and on another sitagliptin plus placebo, in a randomized double-blind fashion. Forearm blood flow was assessed at each visit.
Measured: Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.
Aim 2: Percent Change From Baseline in Forearm Vascular Resistance
Subjects undergo two study days separated by a washout period. On one study day they will receive sitagliptin plus another study drug and on another sitagliptin plus placebo, in a randomized double-blind fashion. Forearm blood flow was assessed at each visit every 30 minutes for 3 hours. This was divided into mean arterial pressure to determine forearm vascular resistance.
Measured: Percent change from baseline in forearm vascular resistance at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes

Secondary outcomes (3)

Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
In Aim 1 subjects underwent two study days separated by a washout period. On one study day they received study drug and on another placebo, in a randomized double-blind fashion. Venous blood samples were obtained at each visit.
Measured: baseline and every 30 minutes for 180 minutes
Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized double-blind fashion. Tissue plasminogen activator activity (tPA) was assessed at each visit.
Measured: baseline and every 30 minutes until 180 minutes
Aim 2: Measurement of Growth Hormone (GH) Levels
Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized double-blind fashion. Growth hormone secretion following arginine stimulation was assessed at each visit. Growth hormone levels were determined using an assay that is not subject to interference by pegvisomant.
Measured: baseline and every 30 minutes until 180 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013May 2017

First posted5 Oct 2012 (estimated)
Study startJan 2013
Primary completionMay 2017
Study completionMay 2017

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.
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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01701973
Sponsor's protocol ID: 120078
Other IDs: 1K23HL119602
Status last verified: May 2018
First submitted: 3 Oct 2012
Last updated: 29 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wilson JR, Brown NJ, Nian H, Yu C, Bidlingmaier M, Devin JK. Dipeptidyl Peptidase-4 Inhibition Potentiates Stimulated Growth Hormone Secretion and Vasodilation in Women. J Am Heart Assoc. 2018 Feb 25;7(5):e008000. doi: 10.1161/JAHA.117.008000.
PubMed 29478970

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Dipeptidyl Peptidase IV Inhibition on Growth Hormone-Mediated Vasodilation
ClinicalTrials.gov ID: NCT01701973
Acronym / sponsor ID: 120078
Conditions: Obesity
Keywords: obesity, growth hormone
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Study start: Jan 2013
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 5 Oct 2012 (estimated)
Results: Posted 29 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study tests the following hypotheses:

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Group A (14 healthy subjects)	Other	Drug: Sitagliptin, Drug: Placebo, Drug: L-NMMAIn Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo. In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either LNMMA (L-N-Monomethyl-arginine) versus placebo.
Group B (14 healthy subjects)	Other	Drug: Sitagliptin, Drug: Pegvisomant, Drug: PlaceboIn Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo. In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either pegvisomant versus placebo.
Group C (14 healthy subjects)	Other	Drug: Sitagliptin, Drug: Placebo, Drug: Exendin 9-39In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo. In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either Exendin 9-39 versus placebo.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age 18 to 40 years inclusive
BMI ≤ 25 kg/m2
For female subjects:
Status-post surgical sterilization, or If of child-bearing potential, utilization of a barrier method of birth control following negative serum pregnancy test at screening visit and on every study day

Key exclusion criteria (14 listed)

Smoking
Type 1 or Type 2 Diabetes Mellitus, as defined by a fasting glucose of 126 mg/dL or greater at the time of screening visit or the use of anti-diabetic medication
Hypertension, as defined by an untreated seated systolic blood pressure (SBP) greater than 140 mmHg and/or an untreated diastolic blood pressure (DBP) greater than 90 mmHg at the time of screening visit or the use of anti-hypertensive medication
History of reported or recorded hypoglycemia (plasma glucose < 70 mg/dL)
Pregnancy and/or Breast-Feeding

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
SitagliptinAlso: JanuviaDuring Aim 1, given on one of two study days (other study day subjects receive placebo.) During Aim 2, given during both of two study days.	Drug	Group A (14 healthy subjects), Group B (14 healthy subjects), Group C (14 healthy subjects)
PegvisomantAlso: SomavertDuring Aim 2, given 72 hours prior to one of two study days (Group B subjects only)	Drug	Group B (14 healthy subjects)
PlaceboAlso: sugar pillDuring Aim 1, given on one of two study days (other study day subjects receive sitagliptin.) During Aim 2, given on one of two study days (other study day subjects receive either L-NMMA, pegvisomant, or Exendin 9-39 pending their group assignment)	Drug	Group A (14 healthy subjects), Group B (14 healthy subjects), Group C (14 healthy subjects)
L-NMMAAlso: L-N-Monomethyl-arginineDuring Aim 2, given during one of two study days (Group A subjects only)	Drug	Group A (14 healthy subjects)
Exendin 9-39During Aim 2, given during one of two study days (Group C subjects only)	Drug	Group C (14 healthy subjects)

Primary outcome

Aim 1: Stimulated Peak Growth Hormone Level
Time frame: Growth Hormone Level at 30 minutes (i.e. at completion of arginine infusion), 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Subjects underwent two study days separated by a washout period. On one study day they will receive sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine (30 grams i.v. over 30 minutes) on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
Aim 1: Percent Change From Baseline in Forearm Vascular Resistance
Time frame: Percent change from baseline in forearm vascular resistance at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Forearm blood flow was determined by strain gauge plethysmography. Forearm vascular resistance was then calculated by dividing this into mean arterial pressure. The percent change from baseline was determined at each timepoint.
Aim 1: Percent Change From Baseline in Forearm Blood Flow
Time frame: Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.
Forearm blood flow was determined by strain gauge plethysmography. The percent change from baseline was determined at each timepoint.
Aim 2: Percent Change From Baseline in Forearm Blood Flow
Time frame: Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.
Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus another study drug and on another sitagliptin plus placebo, in a randomized double-blind fashion. Forearm blood flow was assessed at each visit.
Aim 2: Percent Change From Baseline in Forearm Vascular Resistance
Time frame: Percent change from baseline in forearm vascular resistance at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Subjects undergo two study days separated by a washout period. On one study day they will receive sitagliptin plus another study drug and on another sitagliptin plus placebo, in a randomized double-blind fashion. Forearm blood flow was assessed at each visit every 30 minutes for 3 hours. This was divided into mean arterial pressure to determine forearm vascular resistance.

3 secondary outcomes

Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
Time frame: baseline and every 30 minutes for 180 minutes
Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
Time frame: baseline and every 30 minutes until 180 minutes
Aim 2: Measurement of Growth Hormone (GH) Levels
Time frame: baseline and every 30 minutes until 180 minutes

Results and safety

Results posted to the registry on 29 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aim 1: Sitagliptin, Then Placebo	23	23
Aim 1: Placebo, Then Sitagliptin	21	20
Aim 2: Sitagliptin + Placebo,Then Sitagliptin + LNMMA	0	0
Aim 2:Sitagliptin + LNMMA, Then Sitagliptin + Placebo	0	0
Aim 2: Sitagliptin + Placebo, Then Sitagliptin + Pegvisomant	0	0
Aim 2: Sitagliptin + Pegvisomant, Then Sitagliptin + Placebo	0	0
Aim 2: Sitagliptin + Placebo, Then Sitagliptin + Exendin 9-39	0	0
Aim 2: Sitagliptin + Exendin 9-39, Then Sitagliptin + Placebo	0	0

Primary outcome: Aim 1: Stimulated Peak Growth Hormone Level

Time frame: Growth Hormone Level at 30 minutes (i.e. at completion of arginine infusion), 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes. Mean (Standard Deviation). Unit: ng/ml

Measure	Aim 1: Sitagliptin,Female Participants n = 29	Aim 1: Placebo, Female Participants n = 29	Aim 1: Sitagliptin, Male Participants n = 10	Aim 1: Placebo, Male Participants n = 10
30 minutes	5.2 (4.2)	3.1 (3.3)	1.9 (1.9)	2.0 (2.3)
45 minutes	9.5 (6.1)	6.6 (5.0)	3.4 (3.5)	3.9 (3.3)
60 minutes	9.4 (6.4)	7.0 (6.0)	3.0 (3.6)	3.3 (2.3)
90 minutes	5.0 (3.4)	6.4 (4.8)	1.1 (1.00)	2.1 (2.0)
120 minutes	2.7 (2.1)	4.2 (3.4)	1.5 (3.1)	0.9 (0.8)
150 minutes	1.8 (2.5)	2.4 (2.1)	2.2 (4.3)	1.8 (3.3)
180 minutes	0.9 (0.9)	1.3 (1.9)	1.0 (1.9)	1.0 (1.8)

Population analysed: Data from all subjects who completed both study days in Aim 1 were analyzed. Subjects represented young, healthy adults without any chronic medical conditions and who did not take any medications. Oral birth control use was not permitted.

Primary outcome: Aim 1: Percent Change From Baseline in Forearm Vascular Resistance

Time frame: Percent change from baseline in forearm vascular resistance at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes. Mean (Standard Deviation). Unit: percentage change from baseline

Measure	Aim 1: Sitagliptin,Female Participants n = 29	Aim 1: Placebo, Female Participants n = 29	Aim 1: Sitagliptin, Male Participants n = 10	Aim 1: Placebo, Male Participants n = 10
30 minutes	-5.0677 (18.56794)	-5.3498 (19.60881)	1.4929 (21.57596)	-11.2235 (13.60628)
60 minutes	-5.1365 (16.61555)	-1.0195 (22.62776)	6.7355 (23.96889)	4.6875 (31.77169)
90 minutes	-10.1867 (22.00489)	-1.6694 (31.84989)	1.0144 (28.50393)	-3.8029 (35.33295)
120 minutes	-12.5192 (31.29272)	-5.0763 (26.06546)	-10.3674 (32.22945)	-2.7449 (31.52281)
150 minutes	-24.1962 (23.92090)	-11.8335 (27.88447)	-9.7129 (30.40280)	-7.1590 (30.41909)
180 minutes	-22.4043 (27.60020)	-16.5358 (32.22119)	-11.9609 (20.50786)	-15.0591 (25.33331)

Primary outcome: Aim 1: Percent Change From Baseline in Forearm Blood Flow

Time frame: Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.. Mean (Standard Deviation). Unit: percent change from baseline

Measure	Aim 1: Sitagliptin,Female Participants n = 29	Aim 1: Placebo, Female Participants n = 29	Aim 1: Sitagliptin, Male Participants n = 10	Aim 1: Placebo, Male Participants n = 10
30 minutes	0.4835 (19.44436)	1.6458 (19.42502)	-.0238 (23.86278)	9.2597 (14.60368)
60 minutes	5.3416 (21.33943)	4.9101 (37.42841)	-2.8869 (25.79685)	0.6789 (24.91588)
90 minutes	15.9192 (36.11077)	11.7285 (47.44341)	1.5212 (30.57639)	13.5358 (37.76659)
120 minutes	23.2248 (40.83970)	10.3081 (28.31870)	20.1185 (38.89402)	9.9379 (28.93967)
150 minutes	39.9269 (45.00577)	19.7355 (30.90766)	21.6011 (42.67343)	15.0944 (34.56449)
180 minutes	40.6354 (50.48606)	30.0924 (36.51124)	16.8489 (24.95539)	26.1772 (34.75120)

Primary outcome: Aim 2: Percent Change From Baseline in Forearm Blood Flow

Time frame: Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.. Mean (Standard Error). Unit: percent change from baseline

Measure	Aim 2: Sitagliptin and LNMMA, Female Participants n = 7	Aim 2: Sitagliptin and Placebo, Females in LNMMA Group n = 7	Aim 2: Sitagliptin and LNMMA, Male Participants n = 2	Aim 2: Sitagliptin and Placebo, Males in LNMMA Group n = 2	Aim 2: Sitagliptin and Pegvisomant, Female Participants n = 5	Aim 2: Sitagliptin & Placebo, Females in Pegvisomant Group n = 5	Aim 2: Sitagliptin and Exendin 9-39, Female Participants n = 7	Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group n = 7	Aim 2: Sitagliptin and Exendin 9-39, Male Participant n = 1	Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group n = 1
30 minutes	-0.71 (6.75)	-9.34 (8.60)	5.17 (4.27)	14.78 (14.78)	15.64 (5.06)	0.39 (8.93)	-7.33 (8.66)	-0.98 (12.08)	-7.59 (NA)	-22.67 (NA)
60 minutes	-3.64 (12.68)	-17.06 (12.93)	7.05 (4.06)	4.56 (0.97)	6.58 (10.16)	16.10 (12.79)	-10.54 (8.53)	6.95 (9.53)	9.37 (NA)	-13.00 (NA)
90 minutes	3.24 (10.02)	-6.35 (16.60)	25.69 (6.25)	20.32 (12.83)	36.96 (14.71)	16.67 (33.39)	2.23 (8.69)	2.08 (11.60)	5.36 (NA)	-18.33 (NA)
120 minutes	4.22 (12.54)	9.80 (18.23)	32.92 (0.97)	56.26 (55.06)	54.10 (21.87)	41.97 (31.29)	31.10 (9.04)	22.24 (11.14)	16.52 (NA)	-22.00 (NA)
150 minutes	16.09 (13.00)	11.26 (28.45)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin	0 of 40 (0%)	7 of 40 (17.5%)	0 of 40
Placebo	0 of 43 (0%)	1 of 43 (2.3%)	0 of 43
Sitagliptin Plus Pegvisomant	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Sitagliptin Plus LNMMA	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Sitagliptin Plus Exendin 9-39	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29478970Wilson JR, Brown NJ, Nian H, Yu C, Bidlingmaier M, Devin JK. Dipeptidyl Peptidase-4 Inhibition Potentiates Stimulated Growth Hormone Secretion and Vasodilation in Women. J Am Heart Assoc. 2018 Feb 25;7(5):e008000. doi: 10.1161/JAHA.117.008000.

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Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
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Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

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.

Jessica K Devin, MD, MSCI principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sitagliptin, Pegvisomant and L-NMMA in people with Obesity, run by Vanderbilt University 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 14 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 29 May 2018. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2018). 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?

Aim 1: Stimulated Peak Growth Hormone Level (time frame: Growth Hormone Level at 30 minutes (i.e. at completion of arginine infusion), 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes). The study lists 5 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 NCT01701973, 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 29 May 2018.