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Completed

NCT Number: NCT02550548

Incretin Action in Physiology and Diabetes

This project is designed to advance understanding of the incretin effect in health and disease. This system of gut-islet linkage is essential for normal glucose tolerance, impaired in T2DM, and amenable to therapeutic intervention. However, there are important gaps in understanding incretin function that limit application of this system; this project will address several of these. A secondary, but critical aspect of this research is focus on inter-individual variation in the physiology of the incretin system. This is a novel direction for research in this field and is critical to advancing the concept of individualized medical care in diabetes by establishing whether there is a physiologic basis for predicting the existence of responders and non-responders to incretin therapies.

Currently, we have described only Aim 1 from this grant in this protocol registration. While Aim 2 and 3 are described in the grant, Aim 1 will be conducted first and the results from this Aim and / or the publication of other results in the field may affect the approach to Aims 2 and 3.

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Key information

Conditions

Insulin Secretion

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke Center for Living

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy adult volunteers
  • fasting plasma glucose value ≤ 95 mg/dL, measured at screening visit
  • HbA1c ≤ 5.9%, measured at screening visit

Exclusion criteria

  • history of diabetes diagnosis, including gestational diabetes
  • presence of Type II diabetes mellitus among any first degree family members
  • 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
  • pregnancy
  • uncontrolled hypertension
  • consumption of daily medications that alter glucose metabolism or GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)

Treatment and study plan

GIP infusion

Drug

after establishing a hyperglycemic clamp (target: 125 mg/dL) GIP will be infused

GLP-1 infusion

Drug

after establishing a hyperglycemic clamp (target: 125 mg/dL) GLP-1 will be infused

Ex-9 infusion

Drug

Ex-9 infusion will be initiated at start of hyperglycemic clamp (target: 125 mg/dL)

Primary outcomes

  1. Beta cell sensitivity

    Time frame: 30 minute infusion periods

    Beta-cell sensitivity for each incretin will equal the slope of the insulin secretion rate divided by the specific incretin level (GLP-1 or GIP)

Sponsors and collaborators

Lead sponsor

David D'Alessio, M.D.

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 15, 2015
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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