What Bloodwork Is Required for Growth Hormone Therapy?

The four foundational baseline markers cover GH status, glucose metabolism, and cardiovascular risk. IGF-1 is the primary biomarker for growth hormone status. The marker is measured against age- and sex-adjusted reference range. Fasting glucose establishes insulin resistance baseline. Hemoglobin A1c establishes glycemic baseline given GH secretagogue therapy can worsen insulin resistance. Lipid panel supports cardiovascular risk stratification. Dynamic testing confirms adult-onset GHD diagnosis. The insulin tolerance test is the gold standard. The glucagon stimulation test is the alternative when ITT is contraindicated. The macimorelin test is FDA-approved for adult-onset GHD.

Six Things You Need to Know About GH Bloodwork

This page covers growth hormone secretagogue and replacement therapy baseline bloodwork in detail. The framework spans FDA-approved Tesamorelin and somatropin plus compounded Sermorelin. Section one covers the four foundational baseline markers. Section two covers dynamic testing for adult-onset GHD diagnosis. Section three addresses Tesamorelin HIV-associated lipodystrophy framework. Section four covers the four-stage monitoring cadence.

Research Suggests

How to Approach Your Decision

• For Sermorelin compounded GHRH therapy, expect IGF-1, fasting glucose, A1c, lipid panel plus AMA Code 1.1.5 documentation.
• For Tesamorelin HIV-associated lipodystrophy, expect same four foundational markers plus HIV viral load and CD4 count.
• For somatropin GHD replacement therapy, expect confirmed adult-onset GHD diagnosis through dynamic testing first.
• For dynamic testing, expect insulin tolerance test gold standard or glucagon stimulation or macimorelin alternative.
• For patients with cardiac disease or epilepsy, ITT is contraindicated. Expect glucagon stimulation or macimorelin.
• For compounded Sermorelin, expect 503A or 503B pharmacy verification plus AMA Code 1.1.5 informed consent.
• Expect glucose metabolism monitoring given GH therapy can worsen insulin resistance per FDA Tesamorelin label.
• Expect specialty coordination with endocrinology for GHD diagnosis and ongoing GH therapy monitoring.

Limitations and Caveats

• IGF-1 alone does not diagnose adult-onset GHD. Dynamic testing confirmation is required per AACE 2019 Adult GHD CPG. Normal IGF-1 does not exclude GHD.
• Somatropin replacement therapy requires confirmed GHD diagnosis. The FDA-approved adult indication is diagnosed adult-onset GHD not general anti-aging or off-label use.
• ITT is contraindicated in cardiac disease or epilepsy. Alternative dynamic testing applies including glucagon stimulation test or macimorelin test.
• GH therapy can worsen insulin resistance. Baseline glucose metabolism plus ongoing monitoring is required per FDA Tesamorelin label.
• Compounded Sermorelin operates under AMA Code 1.1.5 framework. Documented informed consent plus 503A or 503B pharmacy verification applies.
• Tesamorelin FDA-approved indication is HIV-associated lipodystrophy. Off-label use for non-HIV indications operates under AMA Code 1.1.5 framework.
• Macimorelin is contraindicated in QT prolongation risk. Cardiac assessment may apply before macimorelin testing.
• Specialty coordination with endocrinology supports the framework. Complex GHD diagnosis and ongoing GH therapy monitoring benefits from specialty input.

What's Marketed vs What's Studied

7 common claims, corrected.

Common Questions

Evidence Ranking

1. Rank 1

   Insulin-like growth factor 1 (IGF-1)

   Strongest evidence anchoring: primary biomarker for GH status per AACE 2019 Adult GHD CPG with age- and sex-adjusted reference ranges across the GH therapy class.

2. Rank 2

   Insulin tolerance test (ITT)

   Strong evidence anchoring: gold standard dynamic test for adult-onset GHD diagnosis per AACE 2019 GHD CPG. Contraindicated in cardiac disease or epilepsy.

3. Rank 3

   Macimorelin test (FDA-approved alternative)

   Strong evidence anchoring: FDA-approved 2017 oral dynamic test for adult-onset GHD diagnosis with 2.8 ng/mL GH peak cutoff per FDA label.

4. Rank 4

   Fasting glucose and A1c

   Strong evidence anchoring: FDA Tesamorelin label specifies glucose monitoring given insulin resistance risk. Baseline plus ongoing monitoring required.

5. Rank 5

   Glucagon stimulation test

   Strong evidence anchoring: most common alternative dynamic test when ITT contraindicated per AACE 2019 GHD CPG.

6. Rank 6

   Lipid panel

   Moderate evidence anchoring: cardiovascular risk stratification baseline. Tesamorelin may modify lipid profile across therapy course.

Sourcing Checklist

• Order baseline bloodwork through prescribing physician with documented clinical interpretation.

  Self-ordered direct-to-consumer bloodwork is not a substitute for physician-ordered baseline. AMA Code 1.1.5 informed consent requires physician clinical interpretation.

• For somatropin therapy, confirm adult-onset GHD diagnosis through dynamic testing first.

  AACE 2019 GHD CPG specifies dynamic testing (ITT gold standard, glucagon stim alternative, macimorelin FDA-approved alternative) for adult-onset GHD diagnosis confirmation.

• For Tesamorelin therapy, confirm HIV-associated lipodystrophy indication per FDA label.

  Tesamorelin Egrifta NDA 022505 FDA-approved indication is HIV-associated lipodystrophy with viral suppression on antiretroviral therapy as typical context.

• For compounded Sermorelin, expect AMA Code 1.1.5 informed consent documentation.

  The documentation includes risk-benefit assessment, FDA-approved alternatives considered (Tesamorelin or somatropin where applicable), monitoring requirements, and patient understanding.

• For compounded Sermorelin, verify 503A or 503B pharmacy quality assurance.

  Verification includes 503A state pharmacy board license or 503B FDA registration, PCAB accreditation, USP Chapter 797 and 800 compliance, and third-party testing practices.

• Expect glucose metabolism monitoring across GH therapy course.

  GH therapy can worsen insulin resistance per FDA Tesamorelin label. Baseline fasting glucose and A1c plus ongoing monitoring captures progression.

• Expect IGF-1 dose titration based on age- and sex-adjusted reference range.

  AACE 2019 GHD CPG specifies IGF-1 dose titration targeting upper half of normal range with monitoring at month 3 and month 6.

• Expect specialty endocrinology coordination for GHD diagnosis and ongoing GH therapy.

  Complex evaluation including dynamic testing and ongoing monitoring benefits from specialty endocrinology input per AACE 2019 GHD CPG.

• For Tesamorelin HIV-associated lipodystrophy contexts, expect infectious disease coordination.

  HIV management framework with viral suppression on antiretroviral therapy is the typical Tesamorelin context. Infectious disease specialty coordination supports the framework.

Regulatory Context

The regulatory framework governing growth hormone therapy evolves continuously. FDA prescribing information for Tesamorelin (Egrifta NDA 022505) and somatropin brands updates with each labeling cycle including new contraindications, monitoring specifications, and adverse event profile updates. AACE Adult GHD Clinical Practice Guidelines update periodically. The FDA Compounding Quality Act enforcement landscape evolves with state pharmacy board oversight cycles for compounded Sermorelin. AMA Code of Medical Ethics 1.1.5 and 2.1.1 frameworks remain foundational. The macimorelin test (FDA-approved 2017) represents the most recent FDA-approved dynamic test for adult-onset GHD diagnosis. PSI tracks regulatory changes and updates this page per the Editorial Standards review cadence.

Who This Applies To

• · Adult with HIV-associated lipodystrophy preparing for Tesamorelin therapy per FDA label.
• · Adult with confirmed adult-onset GHD preparing for somatropin replacement therapy.
• · Adult considering compounded Sermorelin under AMA Code 1.1.5 framework.
• · Adult requiring dynamic testing for adult-onset GHD diagnosis confirmation.
• · Adult with cardiac disease requiring glucagon stimulation or macimorelin alternative to ITT.
• · Adult with pre-diabetes or type 2 diabetes requiring close glucose monitoring during GH therapy.
• · Patient with HIV on antiretroviral therapy with viral suppression considering Tesamorelin.
• · Patient considering off-label compounded GH secretagogue with documented risk-benefit assessment.
• · Patient evaluating telehealth GH consultation with initial screening labs ordering.
• · Patient planning specialty endocrinology coordination for ongoing GH therapy monitoring.

Verdict

Growth hormone therapy requires baseline IGF-1, fasting glucose, A1c, and lipid panel per FDA labels and AACE 2019 Adult GHD CPG. For Tesamorelin HIV-associated lipodystrophy, baseline HIV viral load and CD4 count add. For somatropin GHD replacement, confirmed adult-onset GHD diagnosis through dynamic testing is required. The insulin tolerance test is the gold standard. The glucagon stimulation test and macimorelin test are alternatives. Compounded Sermorelin operates under AMA Code 1.1.5 framework. GH therapy can worsen insulin resistance. Monitoring follows a four-stage cadence across the therapy course. Specialty endocrinology coordination supports the framework.

In Plain Terms

GH drugs include compounded Sermorelin, FDA-approved Tesamorelin (for HIV-associated lipodystrophy), and FDA-approved somatropin (for diagnosed GHD). Before starting, the doctor orders IGF-1, fasting glucose, A1c, and lipid panel. For Tesamorelin, your HIV viral load and CD4 count are also checked. For somatropin, you need a dynamic test to confirm GH deficiency. The insulin tolerance test is the gold standard. The glucagon stimulation test and macimorelin test are alternatives. Bloodwork is repeated at baseline, week 4-8, month 3, and month 6 then yearly.

GH drugs need IGF-1 plus glucose and lipid testing before starting. For somatropin, you need a special dynamic test to confirm GH deficiency. For Tesamorelin, your HIV status is also checked. For compounded Sermorelin, your doctor must document risk-benefit per AMA rules. Bloodwork is repeated at baseline, week 4-8, month 3, and month 6 then yearly. GH therapy can worsen blood sugar so glucose is closely monitored.

For growth hormone therapy, physician selection through state medical board license verification, ABMS board certification (endocrinology preferred for GHD diagnosis contexts), and AMA Code 1.1.5 framework adherence is the legal and clinical gate. PSI maintains a vetted directory of practitioners ordering comprehensive GH baseline bloodwork per FDA prescribing information and AACE 2019 Adult GHD CPG.

Related Conditions

• → Peptides for Growth Hormone Deficiency
• → Peptides for HIV-Associated Lipodystrophy
• → Peptides for Sarcopenia
• → Peptides for Pituitary Disorders
• → Peptides for Body Composition
• → Peptides for Metabolic Health

Related Education

• → Bloodwork Before Peptide Therapy (PARENT)
• → Bloodwork for GLP-1 Therapy
• → Bloodwork for Osteoporosis Peptide Therapy
• → Compounded vs FDA-Approved Peptides
• → Peptide Consultation: What to Expect
• → Finding a Peptide Doctor
• → Red Flags in Peptide Prescribing

Featured Compounds

• → Sermorelin
• → Tesamorelin (Egrifta)
• → Somatropin (Genotropin / Humatrope / Norditropin)
• → Macimorelin (Macrilen)
• → CJC-1295
• → Ipamorelin
• → MK-677 (Ibutamoren)
• → GHRP-2 and GHRP-6

Common Contexts

• · Adult with HIV-associated lipodystrophy preparing for FDA-approved Tesamorelin therapy
• · Adult with confirmed adult-onset GHD preparing for FDA-approved somatropin replacement
• · Adult considering compounded Sermorelin under AMA Code 1.1.5 documentation framework
• · Adult requiring dynamic testing through specialty endocrinology for GHD diagnosis confirmation
• · Adult with cardiac disease requiring glucagon stimulation or macimorelin alternative to ITT
• · Adult with pre-diabetes requiring close glucose monitoring during GH therapy course
• · Patient with HIV on antiretroviral therapy with viral suppression evaluating Tesamorelin candidacy
• · Patient evaluating telehealth GH consultation with initial IGF-1 and glucose screening labs
• · Patient planning specialty endocrinology coordination for ongoing GH therapy monitoring
• · Patient comparing compounded Sermorelin versus FDA-approved Tesamorelin and somatropin pathways

Sources and Citations

1. [1] FDA Prescribing Information: Egrifta (tesamorelin) for HIV-associated lipodystrophy · 2023 · FDA NDA 022505 · Source
2. [2] FDA Prescribing Information: Genotropin (somatropin) for diagnosed GHD · 2023 · FDA NDA 020280 · Source
3. [3] FDA Prescribing Information: Humatrope (somatropin) for diagnosed GHD · 2023 · FDA NDA 019640 · Source
4. [4] FDA Prescribing Information: Macrilen (macimorelin) for adult-onset GHD diagnosis · 2022 · FDA NDA 205598 · Source
5. [5] AACE Adult Growth Hormone Deficiency Clinical Practice Guidelines for Diagnosis and Treatment · Endocrine Practice · 2019
6. [6] Endocrine Society Clinical Practice Guideline: Evaluation and Treatment of Adult Growth Hormone Deficiency · Journal of Clinical Endocrinology and Metabolism · 2011 · DOI
7. [7] Molitch ME, Clemmons DR, Malozowski S, et al. Evaluation and Treatment of Adult Growth Hormone Deficiency: An Endocrine Society Clinical Practice Guideline · Journal of Clinical Endocrinology and Metabolism · 2011 · DOI
8. [8] Garcia JM, Biller BMK, Korbonits M, et al. Macimorelin as a Diagnostic Test for Adult GH Deficiency · Journal of Clinical Endocrinology and Metabolism · 2018 · DOI
9. [9] Falutz J, Allas S, Blot K, et al. Metabolic Effects of a Growth Hormone-Releasing Factor in Patients with HIV (Tesamorelin pivotal trial) · New England Journal of Medicine · 2007 · DOI
10. [10] AMA Code of Medical Ethics Opinion 1.1.5: Off-label and Investigational Use of Pharmaceuticals · American Medical Association · 2024 · Source
11. [11] AMA Code of Medical Ethics Opinion 2.1.1: Informed Consent · American Medical Association · 2024 · Source
12. [12] FDA Discontinuation: Sermorelin acetate (Geref) withdrawn from US market 2008 · US Food and Drug Administration · 2008 · Source
13. [13] FDA Compounding Quality Act of 2013: 503A pharmacy and 503B outsourcing facility framework · US Food and Drug Administration · 2013 · Source
14. [14] FDA MedWatch: The FDA Safety Information and Adverse Event Reporting Program · US Food and Drug Administration · 2024 · Source