Role of Alpha-to-beta Cell Communication to Adapt Insulin Secretion to Insulin Resistance.
Recruiting now · Phase 1
Conditions studied: Diabetes (DM)
In brief
Glucagon secretion from α-cells has long been viewed as primarily a counterregulatory mechanism - e.g. an agent with a role to prevent blood sugar from decreasing to levels that compromise function. Our group, along with other researchers, have begun to identify a much more complex role for α-cells, raising questions about when and how glucagon may influence blood glucose levels. This proposal looks to detail proglucagon peptide secretion from α-cells and the impact this has on β-cell function and glucose tolerance, in preclinical studies of human islets and translational studies in human subjects. This protocol registration describes Aim 2 from this NIH grant which involves 2 study populations and separate protocols but addresses a common question. Aim 3 in the grant is focused on a separate hypothesis and will be conducted and published separately from Aim 2.
Key facts
- Study ID
- NCT07224334
- Run by
- David D'Alessio, M.D.
- People needed
- 30
- Starts
- 2025-12-30
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-02-05
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders
- Personal history of diabetes or pancreatitis
- Personal history of cardiac, gastrointestinal, renal or liver disease
- Immediate family history of diabetes
- Renal insufficiency (eGFR < 60 mL/kg/min)
- Anemia (hematocrit < 34%) as measured at screening visit
- Pregnant females
- Poor vein access
- Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)
- Apparent sensitivity to the study peptide as determined by the skin test
- Aim 2B: Inclusion Criteria:
- Age 35-60
- Body Mass Index (BMI) ≥ 27.0
- Fasting plasma glucose of < 126 mg/dL or HbA1c value < 6.5% as measured at screening visit
- Exclusion Criteria:
- Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders
- Personal history of diabetes or pancreatitis
- Personal history of cardiac, gastrointestinal, renal or liver disease
- Immediate family history of diabetes
- Renal insufficiency (eGFR < 60 mL/kg/min)
- AST and/or ALT levels > 3x the upper limit of the normal range
- Anemia (hematocrit < 34%) as measured at screening visit
- Pregnant females
- Poor vein access
- Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)
Where it is running
- Duke Center for Living — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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