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NCT04938466 · ClinicalTrials.gov registry record

Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy

A clinical trial, sponsored by University of Minnesota.

Completed
Registry status
19
Enrollment target

NCT04938466: Completed study, sponsored by University of Minnesota.

NCT04938466 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04938466 has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
19 participants
Enrollment target

Study Summary

The purpose of the study is to compare quality of life, adherence, insulin resistance, body composition and efficacy of long-acting growth hormone (LAGH) to daily growth hormone (DGH) in children with growth hormone deficiency (GHD). These objectives will be evaluated every 6 months for subjects prior to switch from DGH to LAGH, and 6 months after.

Primary Outcome

Fasting glucose and insulin will be measured using standard laboratory tests in order to calculate homeostatic model assessment of insulin resistance (HOMA-IR). The equation is as follows, fasting plasma glucose (mmol/l) multiplied by fasting serum insulin (mU/l) divided by 22.5. HOMA-IR is a unitless measure with no defined range. Higher scores indicate lower insulin sensitivity/higher insulin resistance. Insulin resistance will be assessed at baseline, 6 months prior to beginning LAGH treatmen

Interventions

  • DRUG Long-Acting Growth Hormone (LAGH)

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2021-08-05
Est. Completion 2024-10-30
University of Minnesota

966 total trials

What the finished NCT04938466 record still lists

NCT04938466 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Long-Acting Growth Hormone (LAGH) is the first listed.

NCT04938466 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04938466 about?

NCT04938466 is a clinical study titled "Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy". The purpose of the study is to compare quality of life, adherence, insulin resistance, body composition and efficacy of long-acting growth hormone (LAGH) to daily growth hormone (DGH) in children with growth hormone deficiency (GHD). These objectives will be evaluated every 6 months for subjects pri...

What is the current status of trial NCT04938466?

This trial is currently completed. The enrollment target is 19 participants. The study started on 2021-08-05. Estimated completion is 2024-10-30.

What interventions are being tested in trial NCT04938466?

The interventions under investigation include: Long-Acting Growth Hormone (LAGH) (DRUG).

Who is sponsoring clinical trial NCT04938466?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04938466, the US trial registry maintained by the National Library of Medicine. NCT04938466 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.