Status:
COMPLETED
Analyse the Effect of Semaglutide on Vascular Structure and Function in Patients With Early Type 2 Diabetes
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This is a phase IV, randomized (1:1), prospective, double-blind, placebo controlled, parallel-group, single center study at the Clinical Research Unit (CRC) of the Department of Nephrology and Hyperte...
Detailed Description
Diabetes mellitus type 2, considered at the beginning as a metabolic disorder, converts into a predominantly vascular disease, once its duration extends over several years or/and when additional cardi...
Eligibility Criteria
Inclusion
- Age of 18 - 75 years
- Diagnosis of type 2 diabetes mellitus: defined by fasting glucose ≥ 126 mg/dl or HbA1c ≥ 6,5 % or on oral single or dual blood glucose lowering medication (held constant for the last 3 months)
- HbA1c ≥ 7.0%
- Male and Female patients (females of child bearing potential must be using adequate contraceptive precautions)
- Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
- Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form
Exclusion
- Any other form of diabetes mellitus than type 2 diabetes mellitus
- Use of insulin, sulfonylurea or GLP-1 analogue within the past 3 months
- Patients with more than two oral blood glucose lowering medication
- HbA1c ≥ 10.5%
- Body mass index \> 40 kg/m²
- Fasting plasma glucose \> 240 mg/dl
- Any form of diabetic retinopathy, macular oedema
- Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m²
- Acute or chronic pancreatitis
- Uncontrolled arterial hypertension (BP ≥ 180/110 mmHg)
- Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 3 months prior to study inclusion
- Congestive heart failure (CHF) NYHA stage III and IV
- Drug or alcohol abuses
- Pregnant or breast-feeding patients
- Subset of patients receiving ASL-MRI, exclusion criteria-
- Patients with contraindications to MRI, including:
- Brain aneurysm clip
- Implanted neural stimulator
- Implanted cardiac pacemaker or defibrillator, or presence of intracardiac wires
- Prosthetic heart valves
- Cochlear implant
- Ocular foreign bodies that might be ferromagnetic (e.g., metal shavings)
- Other implanted medical devices (e.g., insulin pumps)
- Metal shrapnel or bullets still in the body
- Severe claustrophobia
- Tattoos (as determined by the Investigator and Imager)
- Weight in excess of MRI machine capacity
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2025
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT05303857
Start Date
March 3 2022
End Date
April 17 2025
Last Update
June 11 2025
Active Locations (1)
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1
Clinical Research Center, Department of Nephrology and Hypertension, University Hospital Erlangen
Erlangen, Germany, 91054