Actively Recruiting

Phase 1
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT07224334

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

Led by David D'Alessio, M.D. · Updated on 2026-02-05

30

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

Sponsors

D

David D'Alessio, M.D.

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • For Aim 2A: Age 18 to 45 years
  • For Aim 2A: Body Mass Index (BMI) less than 27.0
  • For Aim 2A: Fasting plasma glucose less than or equal to 95 mg/dL or HbA1c less than or equal to 5.8% at screening
  • For Aim 2B: Age 35 to 60 years
  • For Aim 2B: Body Mass Index (BMI) 27.0 or higher
  • For Aim 2B: Fasting plasma glucose less than 126 mg/dL or HbA1c less than 6.5% at screening
Not Eligible

You will not qualify if you...

  • Active medical diseases such as 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 with eGFR less than 60 mL/kg/min
  • Anemia with hematocrit less than 34% at screening
  • Pregnant females
  • Poor vein access
  • Daily use of medications that affect glucose metabolism or gastrointestinal function (glucocorticoids, psychotropics, narcotics, metoclopramide)
  • Known sensitivity to the study peptide as determined by skin testing
  • For Aim 2B: Elevated AST and/or ALT levels greater than 3 times the upper limit of normal

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Duke Center for Living

Durham, North Carolina, United States, 27705

Actively Recruiting

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Research Team

J

Johanna Johnson, MS

CONTACT

A

Alyssa Sudnick, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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