Glucagon challenge in patients with type 2 diabetes mellitus

Completed

• Conditions: Diabetes; 10018424

• Registration Number: NL-OMON33022
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

- Type 2 diabetes mellitus controlled by oral antidiabetics (except for PPAR-gamma agents) for at least one year;
- Age 18 to 65 years;
- Males or females (with regular menstrual cycles if premenopausal);
- Able and willing to provide written informed consent.

Exclusion Criteria

- Use of insulin or PPAR-gamma agents;
- Glycated hemoglobin (HbA1c) > 8%;
- BMI <= 22 kg/m2 and >= 35 kg/m2;
- Any evidence of cardiovascular, pulmonary, renal, hepatic or other major organ system disease as determined by history, physical examination, and routine laboratory tests;
- Uncontrolled hypertension (systolic blood pressure >= 150 mm Hg or a diastolic blood pressure >= 95 mm Hg);
- Use of medication known to affect glucose homeostasis (except for biguanides and sulphonylureas), anti-inflammatory drugs, non-selective beta blockers such as propranolol, oral anticoagulants, systemic glucocorticoids or other immunosuppressive drugs;
- Use of prescription or over-the-counter drug(s) to promote weight loss;
- Pregnancy or breastfeeding;
- 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;
- 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 an investigational drug, biologic agent or device within 90 days prior to screening
- Blood donation within three months and plasma donation within two weeks of screening.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>- Hepatic glucose production<br /><br>- Plasma glucagon, glucose and insulin concentrations<br /><br>- Subcutaneous glucose concentrations<br /><br>- Endothelial function<br /><br>- Ex vivo cytokine responses in whole blood stimulated with LPS & SEB</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>