Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on F... | NCT03141632

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

NCT03141632

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Oct 25, 2017Actual

Enrollment

17Actual

Phase

Phase 2

Conditions

Thirst
Water-Electrolyte Imbalance

Interventions

Dulaglutide
Placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2016Actual

Primary Completion Date

May 2017Actual

Completion Date

May 12, 2017Actual

First Submitted Date

Apr 27, 2017

First Submission Date that Met QC Criteria

May 2, 2017

First Posted Date

May 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2017

Last Update Posted Date

Oct 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dulaglutide	Active Comparator	Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.	Drug: Dulaglutide
Placebo	Placebo Comparator	0.5 ml normal saline (0.9% sodium chloride), sc once weekly for 3 weeks.	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dulaglutide	Drug	Evaluation visit with assessment of fluid intake	Dulaglutide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fluid intake	Fluid intake (ml) during an evaluation visit	8 hours

Secondary Outcomes

Measure	Description	Time Frame
Thirst	Thirst perception	8 hours
Urine volume	Urine volume in ml	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mirjam Christ-Crain, Prof	University Hospital fo Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel		4031	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35134170	Derived	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.

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
C555680	dulaglutide
C068637	calcium D-pantothenate, L-cysteine drug combination