Clinical Research Directory

Predictive Factors and Monitoring Strategies in Steroid-Induced Diabetes

Glucocorticoids are widely used in the management of autoimmune, inflammatory and neoplastic conditions. However, they are associated with significant metabolic effects, including steroid-induced diabetes (SID). SID is typically diagnosed using general criteria for type 2 diabetes, which may be inadequate due to the unique glycemic profile often seen in SID, where postprandial hyperglycemia predominates. This research aims to explore the diagnostic value of CGM during steroid therapy and identify risk factors for SID This is a prospective observational study (n=250) enrolling adults initiating glucocorticoid therapy. Participants will undergo 14-day continuous glucose monitoring (CGM) to assess predictive factors and glycemic profile.

Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes

Glucocorticoids are commonly used in the treatment of autoimmune, inflammatory, and neoplastic diseases. Despite their therapeutic efficacy, they are associated with significant metabolic side effects. In the proposed research, the aim is to assess the metabolic efficacy and safety of fixed-ratio combination therapy (basal insulin + GLP-1 receptor agonist) compared to standard insulin therapy in patients with SID. In a selected group of patients, a randomised clinical trial would be conducted to assess the potential benefits of GLP-1 receptor agonists in the management of SID.

The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes

TITLE: How GLP-1 Analogues prevent steroid-induced diabetes (The GAPSID Study) DESIGN: A double-blind study evaluating how GLP-1 analogues, compared with metformin, prevent hyperglycaemia in response to a 7-day course of dexamethasone (DEX) 6 mg once daily. This is a mechanistic experimental medicine study. AIMS: To evaluate the mechanisms by which GLP-1 analogues reduce steroid-induced hyperglycaemia compared to metformin. OUTCOME MEASURES: * Primary: Glucose tolerance in response to standardised mixed meal test (MMT) lasting for 240 minutes, measured in all participants at baseline and on day 7 DEX. * Secondary: Indices of insulin resistance (M-value), beta-cell function (acute insulin response to glucose) and disposition, as measured by a combined IV glucose tolerance test and hyperinsulinaemic-euglycaemic clamp, performed at baseline and on day 7 DEX. * Exploratory: Tissue specific changes in adipose AMPK determined from adipose and muscle biopsies, taken from a subset of approximately 8 individuals in each group. ELIGIBILITY: People living with pre-diabetes or lifestyle controlled diabetes STUDY DURATION: This study will take place over 3 weeks for each partcipant. Study procedures include 10 days of baseline continuous glucose monitoring (CGM) followed by 7 days of dexamethasone with GLP-1, metformin or placebo. Participants will attend a follow-up visit 3-5 days after completing the 7-day course of study drug. The study will run over a period of 3 years. ANTICIPATED IMPACT: Mechanistic evidence for the use of GLP-1 analogues, compared with metformin, in the treatment of steroid-induced diabetes.