MedDataX Logo

Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake

NCT ID: NCT03141632

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-17

Study Completion Date

2017-05-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to elucidate whether GLP-1 analogues influence not only appetite but also thirst perception. It is hypothesized that GLP-1 analogues reduce fluid intake in healthy volunteers compared to Placebo.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

GLP-1 analogues are well known to stimulate glucose-induced insulin secretion and to reduce energy intake. Recent findings from animal and human studies suggest a role of GLP-1 in regulating water and salt homeostasis. GLP-1 has been shown to reduce fluid intake after an oral salt load or during a meal - pointing to a hypodipsic effect. The aim of this study is to elucidate whether these putative hypodipsic properties of GLP-1 analogues reduce fluid intake in healthy volunteers compared to placebo assessed during an evaluation visit of 8 hours.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thirst Water-Electrolyte Imbalance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blind, placebo control, cross-over design
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blind study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dulaglutide

Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.

Group Type ACTIVE_COMPARATOR

Dulaglutide

Intervention Type DRUG

Evaluation visit with assessment of fluid intake

Placebo

0.5 ml normal saline (0.9% sodium chloride), sc once weekly for 3 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Evaluation visit with assessment of fluid intake

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dulaglutide

Evaluation visit with assessment of fluid intake

Intervention Type DRUG

Placebo

Evaluation visit with assessment of fluid intake

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Verum

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Age 18 to 65 years

Exclusion Criteria

* Known or probable central or nephrogenic Diabetes insipidus, based on patient's history
* Polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia
* Primary Polydipsia, defined as more than 4 liters fluid intake per day
* BMI \<18 or \>30kg/m2
* Pregnancy
* Previous treatment with GLP-1 agonists within the last 3 month
* History of pancreatitis
* Severe renal insufficiency (eGFR (CKD EPI) \<30 ml/min/1,73 m2)
* Cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mirjam Christ-Crain, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital fo Basel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Basel

Basel, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Vukajlovic T, Sailer CO, Asmar A, Jensen BL, Vogt DR, Christ-Crain M, Winzeler B. Effect of a 3-Week Treatment with GLP-1 Receptor Agonists on Vasoactive Hormones in Euvolemic Participants. J Clin Endocrinol Metab. 2022 May 17;107(6):e2581-e2589. doi: 10.1210/clinem/dgac063.

Reference Type DERIVED
PMID: 35134170 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GATE

Identifier Type: -

Identifier Source: org_study_id