A glucagon challenge in healthy volunteers

Completed

• Conditions: Diabetes; 10018424

• Registration Number: NL-OMON31110
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

- Able and willing to provide written informed consent
- Age 18 to 65 years
- Males or females

Exclusion Criteria

- Clinically significant abnormalities in medical history, physical examination or
laboratory examination
- Pregnanant or breast feeding females
- Not able or willing to use an acceptable contraceptive method for study duration
for females (hormonal contraceptives, intra-uterine device or condom/pessary)
- Not able and willing to refrain from smoking and/or xanthine use on study day
- Fasting plasma glucose at screening >= 6.4
- HbA1C >= 7%
- BMI >= 30 kg/m2
- Hypertension (systolic blood pressure >= 140 mm Hg or a diastolic blood pressure >=
95 mm Hg)
- Suspicion of a pheochromocytoma (i.e. Rapid heart rate, palpitations, excessive
sweating, chest pain, upper abdominal pain, severe headaches, tremors, feeling
of anxiety or extreme fright, pale skin)
- Positive urine testing for cocaine, opiates (morphine) and/or THC at screening
- Use of concomitant medication (except hormonal contraceptives)
- Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
- History of alcohol or drug abuse
- Undergoing or have undergone treatment with another investigational drug,
biologic agent or device within 90 days prior to Screening.
- Blood donation within three months of screening

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Serum concentrations of (labelled)glucose, glucagon, insulin, C-peptide, GH and<br /><br>active GLP1, glucose levels with a continuous glucose monitoring device,<br /><br>calculation of hepatic glucose production and expression of glucagon receptor<br /><br>mRNA.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Tolerability of biopsies, glucose monitoring and glucagon challenge</p><br>