NCT03807076

Brief Summary

Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

August 13, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.8 years

First QC Date

January 15, 2019

Last Update Submit

November 28, 2023

Conditions

Acromegaly Due to Pituitary Adenoma

Outcome Measures

Primary Outcomes (1)

  • Growth hormone levels

    Plasma growth hormone area under the curve (AUC)

    240 min

Secondary Outcomes (14)

  • Glucose levels

    240 min

  • GIP levels

    240 min

  • Insulin levels

    240 min

  • C-peptide levels

    240 min

  • Insulin-like growth factor-1 (IGF-1) levels

    240 min

  • +9 more secondary outcomes

Study Arms (2)

GIP-A

OTHER

Infusion of GIP-A alone as a study tool.

Other: GIP-A

Placebo

PLACEBO COMPARATOR

Saline

Other: Placebo

Interventions

GIP-AOTHER

GIP-A

GIP-A
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients under clinical investigation of acromegaly disease with normal kidney function, liver function and hemoglobin levels.

You may not qualify if:

  • Medication for acromegaly, adenectomy, liver disease, uncontrolled anemia, severe heart disease, uncontrolled high blood pressure (\>170/100 mmHg), current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Sciences

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Growth Hormone-Secreting Pituitary Adenoma

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPituitary NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SitePituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Mette H Jensen, MSc

    Department of Biomedical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Industrial PhD student

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 16, 2019

Study Start

August 13, 2019

Primary Completion

June 14, 2023

Study Completion

November 28, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)