Natriuretic Effect of GLP-1in Healthy Non Obese Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 21 December 2015
• Main ID: NCT02130778
• Date of registration: 29/04/2014
• Prospective Registration: No
• Primary sponsor: Clinical Hospital Centre Zagreb
• Public title: Natriuretic Effect of GLP-1in Healthy Non Obese Subjects
• Scientific title: Natriuretic Effect of GLP-1 in Healthy Non Obese Subjects Followed by Oral Sodium Load: A Randomized, Placebo-controlled, Cross-over Study
• Date of first enrolment: April 2014
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02130778
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
• Phase: Phase 0

Countries of recruitment

Croatia

Key inclusion & exclusion criteria

Inclusion Criteria:

Inclusion criteria:

- Participant is =18 and =70 years of age on day of signing informed consent

- Participant is a male, or a female who is unlikely to conceive, as indicated by at
least one "yes" answer to the following questions:

- Patient is a surgically sterilized female

- Patient is a postmenopausal female =45 years of age with >2 years since last
menses

- Patient is a non-sterilized, premenopausal female and agrees to abstain from
heterosexual activity or to use an adequate method of contraception ( Note:
Acceptable methods of birth control are: hormonal contraceptive, intrauterine
device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or
vasectomy)

- BMI =185 and =25

- Healthy as determined by:

- Complete medical history, physical exam and

- Standard 12-lead EKG

- Complete blood count, blood chemistry , urinalysis with microscopy

- Kidney USG

- Participant understands the study procedures, and risks involved with the study and
voluntarily agree to participate by giving informed written consent.

Exclusion Criteria:• History of hypertension, diabetes (ADA guidelines), kidney disease

o Participant has impaired renal function defined as glomerular filtration lower than 90
calculated by Cockcroft-Gault formula and 24 creatinine, also by urinary protein excretion
> 200 mg/day or continuing active urinary sediment

- History of myocardial infarction, cerebrovascular accident or transient ischemic
attack

- History of malignancy within last 5 years

- Current febrile state

- Participant is pregnant or nursing woman

- Failure to give informed consent or comply with the protocol

- Participant has received treatment with an investigational drug within the prior 3
months or is otherwise participating in another clinical trial



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Sodium Excretion by Urination

Intervention(s)

Drug: Synthetic GLP-1 (1.5 pmol/kg/min) dissolved in 500 ml 0.9% saline

Other: 500 ml 0.9% saline

Primary Outcome(s)

Evidence of the positive effect on natriuresis (level of sodium in urin sample) following the of GLP1 infusion [Time Frame: Within the 10 minutes after the infusion synthetic GLP-1 (1.5 pmol/kg/min) dissolved in 500 ml 0.9% saline]

Secondary ID(s)

UHCZagreb

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme Corp.