Limited · human
This study developed and validated a unified chromatographic-mass spectrometric (LC-MS) method for detecting a broad range of prohibited peptide drugs (molecular mass 2–10 kDa) in doping control urine samples. The target analytes spanned five categories: insulins (human and animal-derived, including several analogues and a metabolite), growth hormone-releasing hormones (GHRHs) and their metabolites, insulin-like growth factors (IGF variants), synacthen, gonadorelin, and mechano growth factors. A key goal was simplifying sample preparation by consolidating what are traditionally separate, complex analytical workflows into a single procedure, controlled by five internal standards—one per peptide category. The method was validated as an initial testing procedure and shown to meet nearly all World Anti-Doping Agency (WADA) Minimum Required Performance Levels (MRPLs). As a proof of principle, the method was applied to authentic post-administration urine samples from human subjects dosed with insulins and gonadorelin, demonstrating real-world detection capability. Limitations include that human subject data are limited to proof-of-concept post-administration samples rather than a controlled efficacy or pharmacological trial, and the study's primary focus is analytical method development rather than clinical outcomes.
Journal of mass spectrometry : JMS · Jan 2024DOI ↗ Limited · human
This study investigated a method for detecting a broad range of peptide-based doping agents (molecular mass 2–10 kDa) in blood samples collected for anti-doping control purposes. Researchers developed a simplified, generic sample preparation workflow using mixed-mode solid-phase extraction (SPE), coupled with liquid chromatography and high-resolution mass spectrometry (HRMS; resolution >100,000 FWHM) as an initial testing procedure. The target analytes included multiple insulin variants (human and synthetic analogues such as lispro, aspart, glulisine, detemir, glargine, and others), growth hormone–releasing hormones (sermorelin, CJC-1295, tesamorelin), insulin-like growth factors (Long-R3-IGF-I, R3-IGF-I, Des1-3-IGF-I), and mechano growth factors. The study demonstrated that the method met WADA's Technical Document 2022 (TD2022 MRPL) requirements for minimum required performance levels. Proof-of-principle was shown using real post-administration blood samples from subjects treated with synthetic insulin analogues. A key advantage noted was that blood, unlike urine, contains intact peptide hormones at relatively higher concentrations, simplifying detection. Limitations include the study's primarily analytical/methodological scope and the small number of post-administration samples used for validation.
Analytical science advances · Aug 2022DOI ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. Nonalcoholic fatty liver disease (NAFLD) is common in individuals with obesity and is a significant threat to public health, because it can lead to impaired liver function and liver failure. Growth hormone is a hormone produced in the pituitary gland that helps regulate metabolism and growth. Individuals with obesity, on average, secrete less growth hormone than individuals without obesity. There are data to suggest that growth hormone may help to reduce the amount of fat in the liver, and may also reduce inflamm
ClinicalTrials.gov · Dec 2017View trial ↗ 🧪 TrialLimited · human
Registered N/A interventional trial (completed), with sponsor-posted results. Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and fibrosis. NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group has previously shown that HIV-infected individuals w
ClinicalTrials.gov · Jul 2014View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (terminated), with sponsor-posted results. The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH and improve these body tissues. Healthy men and women age
ClinicalTrials.gov · Aug 2011View trial ↗ 🧪 TrialLimited · human
Registered N/A interventional trial (completed), with sponsor-posted results. HIV-infection and its treatment are often associated with an increase in belly fat, as well as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may contribute independently to increased belly fat and to increased cardiovascular risk through effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly
ClinicalTrials.gov · Dec 2010View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (terminated), with sponsor-posted results. The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH), on the muscle, bone and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the effectiveness of GHRH to raise levels of GH and improve these body tissues. The purpose of the t
ClinicalTrials.gov · Dec 2008View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. PP1- The purpose of this study is to determine whether giving more of the hormone produced by everyone called growth hormone releasing hormone (GHRH) can improve heart function in individuals with congestive heart failure. You must be 50 years old or older, have a diagnosis of congestive heart failure, and have a high likelihood of having lower than normal growth hormone effect. GHRH is approved by the US FDA for treatment in children with growth hormone deficiency because GHRH stimulates Growth Hormone (GH). Its
ClinicalTrials.gov · Nov 2008View trial ↗ 🧪 TrialLimited · human
Registered Phase 4 interventional trial (terminated), with sponsor-posted results. This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease.
ClinicalTrials.gov · Jul 2008View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. Obesity, a condition that occurs when a person has too much body fat, affects about 31% of people in the United States. It is associated with increased risk of diabetes, high blood pressure, high cholesterol, and cardiovascular disease. Abdominal obesity, in particular, is also associated with low levels of growth hormone, a hormone that affects rate of growth and the way the body uses energy. Growth hormone releasing hormone (GHRH) is a substance that makes the body naturally increase its own growth hormone leve
ClinicalTrials.gov · May 2008View trial ↗ 🧪 TrialLimited · human
Registered Phase 3 interventional trial (completed), with sponsor-posted results. Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation
ClinicalTrials.gov · Feb 2008View trial ↗