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CompletedNCT02005198Updated Jan 5, 2017

Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)

An observational study in Growth Hormone Disorder and Adult Growth Hormone Deficiency, sponsored by Novo Nordisk A/S. Completed at 1 site in United States. Open to participants aged 23 Years to 79 Years. Per ClinicalTrials.gov, last updated 2017-01-05.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
98
Ages
23 Years to 79 Years
Sex
All
01

Study summary

This study is conducted in the United States of America (USA). The aim of the study is to assess the minimal important difference (MID) of the TRIM-AGHD.

02

Conditions studied

  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
03

In context

Dwarfism, Pituitary

164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.

This study's enrollment of 98 is below the median of 200 across 37 observational studies indexed under Dwarfism, Pituitary.

Browse Dwarfism, Pituitary studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
23 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with a diagnosis of growth hormone deficiency (GHD), naïve to treatment currently and for at least 6 months prior, who are beginning a new prescription treatment for their GHD. Patients will be selected by sites as per inclusion and exclusion criteria

Inclusion criteria

  • Able to speak read and write English
  • GHD (Growth Hormone Deficiency) treatment naïve which is defined as not being on a prescription treatment for their GHD currently and for at least 6 months
  • Beginning a new prescription GHD treatment and expected to be on this treatment for GHD for a minimum of 6 months
  • GHD of either one of the following criteria: a) Adult onset: subjects who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or traumatic brain injury (TBI), b) Childhood Onset: Subjects who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes
  • Confirmed diagnosis of growth hormone deficiency (if a subject satisfies any one of the three following criteria): a) For the insulin tolerance test (ITT) or glucagon test both performed within the last five years: the validated cut-off for GHD in adults is a peak GH response of below 3.0 ng/mL (3 microg/L), b) For growth hormone releasing hormone (GHRH) +Arginine test performed within the last five years: for those subjects with a body mass index (BMI) below 25 kg/m\^2, a peak GH below 11 ng/mL (microg /L); for BMI 25-30 kg/m\^2, a peak GH below 8 ng/mL (8 microg/L); for BMI above 30 kg/m\^2, a peak GH below 4 ng/mL 341 (4 microg/L ), c) Three or more pituitary hormone deficiencies at screening
  • Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)

Exclusion criteria

Exclusion Criteria:

  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Patients who have been on a prescription medication for treatment of GHD in past 6 months
  • Patients with a total Beck Depression Inventory II (BDI-II) score greater than 25
  • Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
  • Acute severe illness associated with weight loss in the last 6 months (defined as a loss of more than 5.0% total body weight)
  • Active Cushings syndrome within the last 24 months
  • Subject with overt diabetes mellitus
  • Previous participation in this study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
98 participants (actual)
Patient registry
No

Groups and cohorts

  • Survey

    Other: No treatment given

Interventions

  • OtherNo treatment given

    Subject will only fill out a questionnaire when entering the non-interventional study

06

What researchers measure

Primary outcomes

  1. Changes in CGI (Clinician Global Impression Scale)

    Time frame: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment

  2. Changes in PGI (Patient Global Impression Scale)

    Time frame: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Princeton, New Jersey 08540, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02005198
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 9, 2013
Start date
Mar 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jan 5, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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