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Study on Alpha-to-Beta Cell Communication in Diabetes

This study is looking at how cells in your body that make glucagon (alpha-cells) communicate with cells that make insulin (beta-cells) to control blood sugar. Researchers want to understand how this communication helps your body adapt insulin production when you become resistant to insulin. You might receive a drug called exendin-9, which blocks a specific receptor, and/or dexamethasone, which can make your body temporarily resistant to insulin. The main goal is to measure how much insulin your body makes (insulin secretion) both with and without exendin-9. This study is for people aged 18 to 60, with specific eligibility for Aim 2A including ages 18-45, a BMI under 27, and normal fasting blood sugar. The study's current status is unclear, and it plans to enroll 30 participants.

Study design
This is an interventional study with 30 planned participants. It involves two groups (Aim 2A and Aim 2B) with different protocols to answer a common question.
What's involved
You would undergo screening, and if eligible, participate for approximately 4-5 weeks. This includes two 4.5-5 hour procedures involving blood sugar measurements and infusions.
Compensation
Not stated in the trial record.
Follow-up
Insulin secretion will be measured on both study days, with studies completed over 4-5 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07224334

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

Recruiting
PHASE1Ages 18–60InterventionalBasic science
David D'Alessio, M.D.
~30 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested: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/minDexamethasone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insulin secretion
Measured over Insulin secretion rates will be measured on both days of study in subjects participating in Aims 2A and 2B. Studies will be completed over a period of 4-5 weeks
+1 more outcome measured

Conditions

Diabetes (DM)

Explore related trials

Diabetes Mellitus

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • David D'Alessio, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Johanna Johnson, MS
[email protected]
919-660-6766
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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
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

What this trial measures

  • Insulin secretionInsulin secretion rates will be measured on both days of study in subjects participating in Aims 2A and 2B. Studies will be completed over a period of 4-5 weeks

    Insulin secretion rates will be computed from deconvolution of C-peptide concentrations measured from plasma samples taken during the hyperglycemic clamps.

  • Insulin secretion with and without exendin-9: Aims 2A and 2B4-5 weeks

    Insulin secretion rates derived from deconvolution of C-peptide will be the primary outcome for insulin secretion. This measure will be compared within subjects in Aim 2A with the difference between the saline and exendin-9 clamps on each day used as the measure of fasting GLP-1 receptor mediated insulin secretion. Comparison of GLP-1 receptor mediated insulin secretion between the placebo and dexamethasone studies will be used to determine the effect of insulin resistance. Insulin secretion rates will also be compared within subjects in Aim 2B. Here the two different study days, one with saline and one with exendin-9 will be used.