Trial · Interventional

CompletedNot applicableResults postedRegistry data

GLP1R Polymorphisms and Response to GLP1

NCTNCT00588380Other id07-004153

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names Glucagon, does not test it. It appears in the summary.

Overview

Status: Completed
Phase: Not applicable
Enrollment: 88 participants (actual)
Sponsor: Mayo Clinic · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Nov 2007
Primary completion: Sept 2010
Completion: Sept 2010
First posted: 8 Jan 2008 (estimated)
Last update posted: 19 Dec 2011 (estimated)
Conditions: Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20072008200920102011

N/A
GLP1R Polymorphisms and Response to GLP1
NCT00588380
Nov 2007 to Sept 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Glucagon-like Peptide-1 (GLP-1) is an important incretin hormone which acts as a powerful insulin secretagogue. Defects in GLP-1 synthesis and secretion are thought to be part of the pathogenesis of type 2 diabetes. Furthermore GLP-1 based therapy is an important part of the therapeutic armamentarium for the treatment of type 2 diabetes. The GLP-1 receptor (GLP1R) is the principal site of action of GLP-1 and GLP-1 receptor agonists like exenatide and liraglutide. The gene coding for this receptor, GLP1R, is highly polymorphic and contains numerous non-synonymous Single Nucleotide Polymorphisms (nsSNPs) which could potentially alter response to endogenous or exogenous GLP-1 or GLP-1R agonists. Indeed there is some in vitro data to support this concept. We propose to utilize a hyperglycemic clamp to test the insulin secretory response to infused GLP-1 in healthy volunteers to determine the effect of genetic variation in GLP1R on response to GLP-1.

Interventions

GLP-1Drug

Arms1

Experimental
GLP-1
All participants recieved GLP-1 intravenously at 0.75 pmol/kg/min for the first hour and then at 1.5 pmol/kg/min for the next hour

Primary outcomes1

Outcomes the sponsor listed as primary.

Insulin Secretion at 150-180 Minutes.
Time frame · 150 - 180 minutes after GLP-1 infusion
Registry description
The 180 minute value represents the mean of the values obtained at 150, 160, 170, and 180 minutes.

Secondary outcomes(1)

Insulin Secretion at 210-240 Minutes
Time frame · 210 - 240 minutes after GLP-1 infusion
Registry description
The 240 minute value represents the mean of values obtained at 210, 220, 230, and 240 minutes.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 150 - 180 minutes after GLP-1 infusion

Insulin Secretion at 150-180 Minutes.

Group	Value (10^-9 min^-1)	Spread
All Participants	104	9

Secondary and other outcome results(1)

Secondary outcomeMean· 210 - 240 minutes after GLP-1 infusion

Insulin Secretion at 210-240 Minutes

Group	Value (10^-9 min^-1)	Spread
Overall Study	152	12

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Overall StudyAll participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.	–	0 / 88	0 / 88

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultSathananthan A, Man CD, Micheletto F, Zinsmeister AR, Camilleri M, Giesler PD, Laugen JM, Toffolo G, Rizza RA, Cobelli C, Vella A. Common genetic variation in GLP1R and insulin secretion in response to exogenous GLP-1 in nondiabetic subjects: a pilot study. Diabetes Care. 2010 Sep;33(9):2074-6. doi: 10.2337/dc10-0200. PMID 20805279

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 40 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Aged 18-40 * fasting glucose concentration of less than 95 mg/dl. Exclusion Criteria: * Individuals with a BMI \< 19 or \> 40 kg/m\^2 * active systemic illness * medication that can alter gastric emptying, insulin secretion \& action * history of abdominal surgery (other than appendectomy or tubal ligation).

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