Healthy
Conditions
Brief summary
The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in the control of blood sugar level by enhancing insulin secretion from the pancreas after eating a meal. The purpose of this research study to find out how genetic variations in GLP1R alter insulin secretion, in the fasting state and when blood sugars levels are elevated.
Interventions
OTHERSaline
Saline will serve as the control
BIOLOGICALExendin-9,39
Exendin-9,39 will block the GLP-1 receptor
BIOLOGICALLiraglutide
Liraglutide will serve as the GLP-1 receptor agonist/stimulator
Sponsors
Adrian Vella
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 40 nondiabetic subjects will be recruited. * 20 subjects with the AA or AG genotype at rs3765467 and remainder will have the GG genotype. * Individuals encompassing the age span of 18-65 years.
Exclusion criteria
* Individuals under 18 and over 65 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Insulin Secretion in Response to Hyperglycemia | insulin secretion rate at the end of the hyperglycemic clamp i.e.: 180 minutes | Insulin secretion was estimated from C-peptide concentrations using the deconvolution method which incorporates c-peptide kinetics, and the subject's age, body surface area, body mass index, and diabetes status. A hyperglycemic clamp will be used which allows the glucose to be maintained at 160mg/dL (9mmol/L). C-peptide concentrations were drawn every 10 minutes from -30 minutes to 180 minutes, and the insulin secretion at 180 minutes was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glucagon Secretion Rate Measured by Immunoassay | 0 Minutes, 180 Minutes | The Glucagon secretion rate during fasting (0 minutes) and at the end of the hyperglycemic clamp (180 minutes). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdrian Vella, MD
Mayo Clinic
Participant flow
Pre-assignment details
21subjects were enrolled in the study, however 1 subject was excluded prior to receiving the study treatment (met exclusion criteria) 3 subjects lost to follow up, 1 lost IV during one study).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 3.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 4 / 17 | 3 / 17 | 7 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 1 / 17 |
Outcome results
None listed