## Protocol Section
### Identification Module
**NCT ID:** NCT00647179

**Brief Title:** Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment

**Official Title:** Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment

#### Organization Study ID Info
**ID:** MM-ISA-20070130
#### Organization
**Class:** OTHER
**Full Name:** University of Aarhus
#### Secondary ID Infos
**ID:** M-20070130
### Status Module
#### Completion Date
**Date:** 2016-12-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-12-26

**Type:** ACTUAL

**Last Update Submit Date:** 2017-12-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-12-07

**Type:** ACTUAL

#### Start Date
**Date:** 2008-02

**Status Verified Date:** 2017-12

#### Study First Post Date
**Date:** 2008-03-31
**Type:** ESTIMATED
**Study First Submit Date:** 2008-03-26
**Study First Submit QC Date:** 2008-03-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Aarhus University Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Aarhus

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment.

### Conditions Module

**Conditions:**

- Acromegaly

- Excessive Growth Hormone Secretion

- Insulin Resistance

**Keywords:**

- Acromegaly

- Growth Hormone

- Insulin resistance

- Glucose tolerance

- Body Composition

- Substrate metabolism

### Design Module

#### Bio Spec

**Description:** Whole blood, serum, muscle samples, fat samples

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 27

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients recently diagnosed with acromegaly

**Intervention Names:**

- Procedure: Transsphenoidal adenomectomy

**Label:** 1

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** Surgery

**Name:** Transsphenoidal adenomectomy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Insulin sensitivity

**Time Frame:** Before and after treatment

#### Secondary Outcomes

**Measure:** QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, Glucose tolerance

**Time Frame:** Before and after treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Written consent
* Age between 18 and 70
* Recently diagnosed with acromegaly

Exclusion Criteria:

* NYHA 3
* Uncontrolled hypertension
* Known cerebrovascular disease
* Proliferative retinopatia

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patiens recently diagnoses with acromegaly, recruited from the clinic

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aarhus C

**Country:** Denmark

**Facility:** Department of Endocrinology, Aarhus University Hospital

**State:** Aarhus

**Zip:** DK-8000

#### Overall Officials

**Official 1:**

**Affiliation:** Aarhus University Hospital, Department of Endocrinology

**Name:** Jens Otto L. Jørgensen, Professor MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Arlien-Soborg MC, Grondahl C, Baek A, Dal J, Madsen M, Hogild ML, Pedersen SB, Bjerre M, Jorgensen JOL. Fibroblast Activation Protein is a GH Target: A Prospective Study of Patients with Acromegaly Before and After Treatment. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz033. doi: 10.1210/clinem/dgz033.

**PMID:** 31544947

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000001849

- Term: Bone Diseases, Endocrine

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000006964

- Term: Hyperpituitarism

- ID: D000010900

- Term: Pituitary Diseases

- ID: D000007027

- Term: Hypothalamic Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10370

- Name: Insulin Resistance

- Relevance: HIGH

- As Found: Insulin Resistance

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M3531

- Name: Acromegaly

- Relevance: HIGH

- As Found: Acromegaly

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5128

- Name: Bone Diseases, Endocrine

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13791

- Name: Pituitary Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10077

- Name: Hypothalamic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T139

- Name: Acromegaly

- Relevance: HIGH

- As Found: Acromegaly

### Condition Browse Module - Meshes

- ID: D000000172

- Term: Acromegaly

- ID: D000007333

- Term: Insulin Resistance

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
