## Protocol Section
### Identification Module
**NCT ID:** NCT00774579

**Brief Title:** The Effect of Growth Hormone Replacement on Liver Fat

**Official Title:** Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect on Liver Fat.

#### Organization Study ID Info
**ID:** GHD1
#### Organization
**Class:** OTHER
**Full Name:** Imperial College London
### Status Module
#### Completion Date
**Date:** 2009-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-07-12

**Type:** ACTUAL

**Last Update Submit Date:** 2019-04-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-03

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-07-12

**Type:** ACTUAL

**Results First Submit Date:** 2019-04-29

**Results First Submit QC Date:** 2019-04-29

#### Start Date
**Date:** 2008-03

**Status Verified Date:** 2009-12

#### Study First Post Date
**Date:** 2008-10-17
**Type:** ESTIMATED
**Study First Submit Date:** 2008-10-16
**Study First Submit QC Date:** 2008-10-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Novo Nordisk A/S

#### Lead Sponsor

**Class:** OTHER

**Name:** Imperial College London

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** We will examine a cohort of growth hormone deficient adults starting growth hormone (GH) replacement. The purpose of this study is to determine whether GH replacement reduces the fat content of the liver.

To compare the results we will include growth hormone deficient patients who do not start GH replacement as controls.

**Detailed Description:** Adults with untreated growth hormone deficiency (GHD), a condition mostly due to pituitary disease, often show metabolic features similar to those described in the 'metabolic syndrome'. Growth hormone (GH) replacement has been shown to reverse many of these unfavorable changes, with a particular evident reduction of visceral fat. In recent years, a strong correlation between fat accumulation in the liver and features of the metabolic syndrome (particularly visceral fat) has been identified, and 'fatty liver' is now being referred as the hepatic feature of the 'metabolic syndrome'. The effect of GH replacement on liver fat, however, has never been systematically studied.

We will assess 15 patients with GHD before and 6 months after starting GH replacement. We will also assess 15 control patients with GHD but who don't go on GH replacement for various reasons.

Liver fat will be assessed using MR spectroscopy. Changes in liver fat will be correlated to changes in insulin sensitivity and changes in various inflammatory markers.

### Conditions Module

**Conditions:**

- Growth Hormone, Recombinant

- Fatty Liver

**Keywords:**

- growth hormone

- growth hormone deficiency

- liver fat

- liver steatosis

- growth hormone replacement

### Design Module

#### Bio Spec

**Description:** plasma, serum, leucocytes, 24-hour urine

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with growth hormone (GH) deficiency starting GH replacement.

**Label:** 1

#### Arm Group 2

**Description:** Patients with growth hormone (GH) deficiency not starting GH replacement.

**Label:** 2

### Outcomes Module

#### Primary Outcomes

**Description:** IHCL content determined by proton magnetic resonance spectroscopy (1H MRS).

**Measure:** Intrahepatocellular Lipid (IHCL) Content

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** total adipose tissue assessed by MRI scan

**Measure:** Total Adipose Tissue

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 20-70 years of age
* Growth hormone deficiency, with (cohort 1) or without (cohort 2) planned growth hormone (GH) replacement
* clinically stable

Exclusion Criteria:

* known hepatic disease
* Acromegaly
* Diabetes mellitus
* growth hormone replacement within the last 12 months
* cushing's disease, if not cured for at least 12 months
* any contraindication to MR studies as set out in the MR safety questionnaire

**Maximum Age:** 70 Years

**Minimum Age:** 20 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients will be recruited from the endocrine clinics of Imperial College Healthcare NHS Trust.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** London

**Country:** United Kingdom

**Facility:** Endocrinology & Metabolic Medicine, Imperial College

**Zip:** W2 1NY

#### Overall Officials

**Official 1:**

**Affiliation:** Imperial College London

**Name:** Fabian A Meienberg, Dr

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Imperial College London

**Name:** Stephen Robinson, Dr

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Imperial College London

**Name:** Jeremy Cox, Dr

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** Imperial College London

**Name:** Ian Godsland, Dr

**Role:** STUDY_CHAIR

**Official 5:**

**Affiliation:** Imperial College London

**Name:** Jimmy Bell, Dr

**Role:** STUDY_CHAIR

**Official 6:**

**Affiliation:** Imperial College London

**Name:** Desmond G Johnston, Prof

**Role:** PRINCIPAL_INVESTIGATOR

**Official 7:**

**Affiliation:** Imperial College London

**Name:** Simon Taylor-Robinson, Prof

**Role:** STUDY_CHAIR

**Official 8:**

**Affiliation:** Imperial College London

**Name:** Emma Hatfield, Dr

**Role:** STUDY_CHAIR

**Official 9:**

**Affiliation:** Imperial College London

**Name:** Michael Yee, Dr

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Meienberg F, Yee M, Johnston D, Cox J, Robinson S, Bell JD, Thomas EL, Taylor-Robinson SD, Godsland I. Liver fat in adults with GH deficiency: comparison to matched controls and the effect of GH replacement. Clin Endocrinol (Oxf). 2016 Jul;85(1):76-84. doi: 10.1111/cen.13042. Epub 2016 Mar 22.

**PMID:** 26895949

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M8375

- Name: Fatty Liver

- Relevance: HIGH

- As Found: Fatty Liver

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5868

- Name: Visceral Steatosis

- Relevance: LOW

- As Found: Unknown

- ID: T2633

- Name: Growth Hormone Deficiency

- Relevance: HIGH

- As Found: Growth Hormone Deficiency

- ID: T3125

- Name: Isolated Growth Hormone Deficiency

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005234

- Term: Fatty Liver

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** GH Replacement

**Description:** Patients with growth hormone (GH) deficiency starting GH replacement.

**ID:** EG000

**Other Num at Risk:** 9

**Serious Number At Risk:** 9

**Title:** GH Replacement

**Group ID:** EG001

**Title:** Control

**Description:** Patients with growth hormone (GH) deficiency not starting GH replacement.

**ID:** EG001

**Other Num at Risk:** 9

**Serious Number At Risk:** 9

**Title:** Control

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 9

**Group ID:** BG001

**Value:** 9

**Group ID:** BG002

**Value:** 18

**Units:** Participants

### Group

**ID:** BG000

**Title:** GH Replacement

**Description:** Patients with growth hormone (GH) deficiency starting GH replacement.

### Group

**ID:** BG001

**Title:** Control

**Description:** Patients with growth hormone (GH) deficiency not starting GH replacement.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8

**Value:** 53

#### Measurement

**Group ID:** BG001

**Spread:** 9

**Value:** 52

#### Measurement

**Group ID:** BG002

**Spread:** 9

**Value:** 52

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 18

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 18

**Class Title:** United Kingdom

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** desmond.johnston@imperial.ac.uk
**Organization:** Imperial College Healthcare London
**Phone:** 020 3312 1253
**Title:** Prof. Desmond Johnston
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.6
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.1
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.53
- **Upper Limit:** 
- **Value:** -0.63
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.46
- **Upper Limit:** 
- **Value:** 0.11
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.2
- **Upper Limit:** 
- **Value:** -1.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.28
- **Upper Limit:** 
- **Value:** 0.24
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** IHCL content determined by proton magnetic resonance spectroscopy (1H MRS).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Intrahepatocellular Lipid (IHCL) Content
**Type:** PRIMARY
**Unit of Measure:** % change from baseline
##### Group
**Description:** Patients with growth hormone (GH) deficiency starting GH replacement.
**ID:** OG000
**Title:** GH Replacement
##### Group
**Description:** Patients with growth hormone (GH) deficiency not starting GH replacement.
**ID:** OG001
**Title:** Control
#### Outcome Measure 2
**Description:** total adipose tissue assessed by MRI scan
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Total Adipose Tissue
**Type:** SECONDARY
**Unit of Measure:** kg
##### Group
**Description:** Patients with growth hormone (GH) deficiency starting GH replacement.
**ID:** OG000
**Title:** GH Replacement
##### Group
**Description:** Patients with growth hormone (GH) deficiency not starting GH replacement.
**ID:** OG001
**Title:** Control
### Participant Flow Module
#### Group
**Description:** Patients with growth hormone (GH) deficiency starting GH replacement.
**ID:** FG000
**Title:** GH Replacement
#### Group
**Description:** Patients with growth hormone (GH) deficiency not starting GH replacement.
**ID:** FG001
**Title:** Control
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 9
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 9
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Recruitment Details:** Between April 2008 and April 2009 adult hypopituitary patients with untreated GHD were identified and recruited at the endocrine clinics of Imperial College Healthcare NHS Trust.
**Has Results:** True