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RecruitingAccepts healthy volunteersPhase 1

Role of Alpha-to-beta Cell Communication to Adapt Insulin Secretion to Insulin Resistance.

David D'Alessio, M.D. · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT07224334

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–60 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
30
US sites recruiting
1
Study start
December 30, 2025
Record last updated
October 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Exendin-9 is a 30 amino acid peptide that is an established competitive antagonist of the GLP-1 receptor. Subjects will receive exendin-9 by intravenous infusion at a rate of 600 pmol/kg/min; Dexamethasone; Dextrose 20% solution; Dextrose 20% solution

Conditions: Diabetes (DM)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Aim 2A and 2A sub-study: Inclusion Criteria:

  • Age 18-45
  • Body Mass Index (BMI) \< 27.0
  • Fasting plasma glucose of ≤ 95 mg/dL or HbA1c value ≤ 5.8% 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)
  • 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)
  • Apparent sensitivity to the study peptide as determined by the skin test

Recruiting US locations

  • Duke Center for Living

    Durham, NC 27705

    Site contact: Johanna Johnson, MS · 919-660-6766 · johanna.johnson@duke.edu

Study contacts (from the official record)

  • Johanna Johnson, MS · 919-660-6766 · johanna.johnson@duke.edu
  • Alyssa Sudnick, MS · 919-660-6769 · alyssa.sudnick@duke.edu
All diabetes studies in North Carolina →
Role of Alpha-to-beta Cell Communication to Adapt Insulin… (NCT07224334) | Bored Studies