DPP4 Inhibition & Beta Cell Function
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 35 - 70 |
| Updated: | 4/28/2018 |
| Start Date: | September 2016 |
| End Date: | March 16, 2018 |
Role of Alpha-cell GLP-1 in the Beta-cell Response to DPP-4 Inhibition
This study is being done to determine the role of a hormone, glucagon-like peptide 1 (GLP-1),
on insulin secretion and to study how GLP-1 works in in diabetic individuals as compared to
non-diabetic individuals, under fasting conditions.
GLP-1 is a naturally occurring hormone made in the intestines. It is released into the
circulating blood after eating and helps to control the blood glucose levels by increasing
insulin secretion by cells in the pancreas. However, the exact method by which GLP-1 causes
insulin secretion and how GLP-1 activity is changed in diabetic persons remain unclear. This
research is being done to address these questions and better understand the function of
GLP-1.
In this research, the investigators will use a synthetic form of Exendin-9 to determine the
effects of GLP-1 on insulin secretion in diabetic and non-diabetic persons. Exendin-9 acts as
a blocker of GLP-1 action, allowing us to study the specific effects of the GLP-1 hormone.
Exendin-9 is an investigational compound, which means it is still being tested in research
studies and is not approved by the U.S. Food and Drug Administration (FDA).
In this study, the investigators will also use the drug Sitagliptin, which is an FDA-approved
drug for the treatment of type 2 diabetes mellitus. In this study, use of Sitagliptin is
considered investigational since it is not being used for treatment of diabetes but is
instead being used to understand how GLP-1 works and to better understand how medications
like Sitagliptin work in patients with type 2 diabetes mellitus.
on insulin secretion and to study how GLP-1 works in in diabetic individuals as compared to
non-diabetic individuals, under fasting conditions.
GLP-1 is a naturally occurring hormone made in the intestines. It is released into the
circulating blood after eating and helps to control the blood glucose levels by increasing
insulin secretion by cells in the pancreas. However, the exact method by which GLP-1 causes
insulin secretion and how GLP-1 activity is changed in diabetic persons remain unclear. This
research is being done to address these questions and better understand the function of
GLP-1.
In this research, the investigators will use a synthetic form of Exendin-9 to determine the
effects of GLP-1 on insulin secretion in diabetic and non-diabetic persons. Exendin-9 acts as
a blocker of GLP-1 action, allowing us to study the specific effects of the GLP-1 hormone.
Exendin-9 is an investigational compound, which means it is still being tested in research
studies and is not approved by the U.S. Food and Drug Administration (FDA).
In this study, the investigators will also use the drug Sitagliptin, which is an FDA-approved
drug for the treatment of type 2 diabetes mellitus. In this study, use of Sitagliptin is
considered investigational since it is not being used for treatment of diabetes but is
instead being used to understand how GLP-1 works and to better understand how medications
like Sitagliptin work in patients with type 2 diabetes mellitus.
Inclusion Criteria:
- Diabetic cohort: adults age 35-70 years with Type 2 diabetes managed by an oral
medication or diet and exercise
- Non-diabetic cohort: healthy adults age 35-70 years
- Male or female
- Ability to speak and understand English
- Diabetic cohort: HbA1c ≤ 8.0%
- Non-diabetic cohort: HbA1c ≤ 6.2%
Exclusion Criteria:
- Rheumatoid arthritis
- Inflammatory bowel disease
- Unstable angina or uncompensated heart failure
- Pulmonary disorders, including COPD and asthma
- Malabsorptive GI disease, such as celiac disease, or gastric bypass
- Significant hepatic disease
- Renal insufficiency (eGFR < 60 mL/kg/min)
- Anemia (hematocrit < 34%) as measured at screening visit
- Uncontrolled hypertension
- Pregnant females
- Consumption of daily medications that alter glucose metabolism of GI function
(glucocorticoids, psychotropics, narcotics, metoclopramide)
- Consumption or injection of insulin
- Apparent sensitivity to any of the study peptides as determined by the skin test
We found this trial at
1
site
Durham, North Carolina 27707
Principal Investigator: David D'Alessio, MD
Phone: 919-660-6782
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