Effects of treatment with GLP-1 receptor agonists on the HPA-axis in type 2 diabetes

Phase 1

• Conditions: Type 2 diabetes; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2018-003566-13-NL
• Lead Sponsor: Radboud university medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-17
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Inclusion criteria (patients with treatment response)
-Age =18 years
-Subject is diagnosed with type 2 diabetes
-Subject showed response to GLP-1RA treatment (decrease in HbA1c =5 mmol/mol and/or weight loss =5%)
-Ability to sign informed consent

Inclusion criteria (patients without treatment response)
-Age =18 years
-Subject is diagnosed with type 2 diabetes
-Subject showed no response to GLP-1RA treatment (decrease in HbA1c <5 mmol/mol and no weight loss)
-Ability to sign informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of the normal range
- Renal disease defined as MDRD <40 ml/min/1.73 m^2
- Pregnancy or the wish to become pregnant within 6 months after the study
- Breastfeeding
- Age <18 years
- Pituitary disorder
- lnability to sign informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main study parameter is the comparison of pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.;Secondary Objective: To assess the metabolic status of the patients by obtaining laboratory parameters, oral glucose tolerance testing, stimulated ACTH assay and urinary cortisol excretion tests.;Primary end point(s): The main study parameter is the comparison of pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.;Timepoint(s) of evaluation of this end point: 1.5 hour after the administration of the tracer

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To assess the metabolic status of the patients by obtaining laboratory parameters, oral glucose tolerance testing, stimulated ACTH assay and urinary cortisol excretion tests.;Timepoint(s) of evaluation of this end point: After the analysis of all tests and PET/CT scan