Glucagon challenge in patients with type 2 diabetes mellitus

Glucagon challenge in patients with type 2 diabetes mellitus - Glucagon challenge T2DM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33022

Enrollment

Registered

2009-08-21

Start date

2009-10-29

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Use of insulin or PPAR-gamma agents; - Glycated hemoglobin (HbA1c) > 8%; - BMI = 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.

Design outcomes

Primary

Measure	Time frame
- Hepatic glucose production - Plasma glucagon, glucose and insulin concentrations - Subcutaneous glucose concentrations - Endothelial function - Ex vivo cytokine responses in whole blood stimulated with LPS & SEB	—

Countries

Netherlands

Outcome results