Health TrialsbyHealthPanel

Studies of Insulin and Glucagon Action in the Liver

ConditionDiabetes (DM)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-45
SponsorDuke University

About this trial

This study examines how glucagon works to regulate glucose metabolism, based on new findings that suggest glucagon signaling in the liver has more than one role, and that these multiple roles can be opposing in nature. Understanding this biology provides an opportunity to develop new generations of glucagon-based drugs that target specific pathways, making them more effective at controlling blood glucose.

Participants will complete paired, 5-hour hyperinsulinemic glucose clamp visits in which they receive either glucagon or saline infusions while blood glucose is maintained and frequent blood samples are collected. The primary focus is whether coordinated glucagon and insulin signaling enhances hepatic insulin sensitivity.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults age 18-45 years

Body Mass Index (BMI) < 27.0 kg/m²

Fasting plasma glucose ≤ 95 mg/dL or HbA1c ≤ 5.8% as measured at screening visit

Disqualifiers

Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders

No personal history of diabetes or pancreatitis

No personal history of cardiac, gastrointestinal, renal or liver disease

No history of diabetes among any first-degree family members

Trial design

Design model

Crossover

Treatments tested in this trial

  • Glucagon

    Drug

    Glucagon infusion either graded (0.2→0.4→0.6 ng/kg/min) or continuous (0.4 ng/kg/min) during the final 90 minutes of a hyperinsulinemic glucose clamp. The graded or continuous glucagon infusions are given as a component of 2 separate protocols. Glucagon prepared per pharmacy/bedside protocol.

  • Saline (placebo)

    Drug

    IV saline infusion during clamp for 90 minutes as control.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Glucagon infusion during hyperinsulinemic clampExperimental treatment 1 intervention
Group B: Saline infusion during hyperinsulinemic clampPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glucose appearance (Ra)

Glucose appearance will be determined using steady state computations, unless a stable tracer:tracee ratio is not maintained

Time frame
In these experiments outcomes will be based on measurements made in the final 90 minutes of the hyperinsulinemic glucose clamp.
2

Glucose disappearance (Rd)

Glucose disappearance (Rd) will be determined using steady state computations, unless a stable tracer:tracee ratio is not maintained

Time frame
In the experiments described here glucose turnover (Ra and Rd) will be determined in the final 90 minutes of the hyperinsulinemic glucose clamp.
3

Hepatic insulin sensitivity

Hepatic insulin sensitivity will be calculated as EGP divided by insulin concentration

Time frame
Basal period (time -30-0 min), after the insulin infusion alone (60-90 min), and during the glucagon/saline infusions (120-180 min)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: