Diabetes, Steroid-Induced Diabetes, Steroid-Induced Hyperglycemia
Conditions
Keywords
Steroid-induced diabetes, GLP-1 receptor agonist, Diabetes
Brief summary
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.
Detailed description
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. Their strongly diabetogenic effect results from the enhanced activity of hyperglycemic hormones, increased insulin resistance, and impaired function of pancreatic β-cells. Current clinical guidelines classify SID as a form of drug-induced diabetes, with insulin therapy as the primary treatment. However, recent studies highlight the role of glucocorticoids in exacerbating insulin resistance, inhibiting incretin effects, and promoting weight gain-factors that suggest a potential therapeutic role for GLP-1 receptor agonists. It is estimated that approximately 100 patients will be needed to achieve statistically significant results. Participants will be stratified based on the type of diabetes (type 2 diabetes vs. steroid-induced diabetes), followed by alternate randomisation into one of two therapeutic groups: Group 1: Patients receiving insulin therapy Group 2: Patients receiving an FRC therapy (insulin glargine and lixisenatide) A clinical research team will perform body composition analysis using bioelectrical impedance analysis (BIA) with a Tanita scale. To assess baseline metabolic control, blood samples will be taken. All study participants will be equipped with a CGM sensor integrated with the hospital clinic system, allowing the study team access to the patients' glycemic data. Participants assigned to Group 1 will receive standard insulin therapy. Those in Group 2 will be treated with a combination of insulin glargine and lixisenatide, with dosages individually adjusted based on current glucose levels. All participants will be trained in insulin administration and dose adjustment based on glucose readings. After hospital discharge, patients will continue to be monitored by the study team using data from the CGM system. The researcher will frequently assess the Glucose Management Indicator (GMI), Time in Range (TIR), daily insulin requirements, and frequency of hypoglycemic episodes. Follow-up phone calls will be attempted every 2 months. If two consecutive contact attempts are unsuccessful, the study will continue based solely on CGM data. A final follow-up visit will take place after 6 months. During this visit, body composition will be reassessed, and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) will be administered to evaluate patient-reported quality of life.
Interventions
DRUGlixisenatide + glargine
Participants assigned to Group 1 will receive standard insulin therapy. Those in Group 2 will be treated with a combination of insulin glargine and lixisenatide, with dosages individually adjusted based on current glucose levels. All participants will be trained in insulin administration and dose adjustment based on glucose readings.
Participants assigned to Group 1 will receive standard insulin therapy. Those in Group 2 will be treated with a combination of insulin glargine and lixisenatide, with dosages individually adjusted based on current glucose levels. All participants will be trained in insulin administration and dose adjustment based on glucose readings.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years of age) * Patients with type 2 diabetes and SIH, or diagnosed with SID requiring insulin * Patients undergoing long-term oral GC therapy for the following indications: * Nephrotic syndrome * Asthma * Rheumatoid arthritis * Psoriatic arthritis * Polymyalgia rheumatica * Synovitis associated with osteoarthritis * Sarcoidosis * Tubulointerstitial nephritis * Atopic dermatitis * Pemphigus * Informed consent
Exclusion criteria
* \- Age \<18 years * Type 1 diabetes * Critically ill patients in a life-threatening condition requiring intensive care and medical support to sustain vital functions, as defined by an Allgöwer index \>1.0 * eGFR \<30 mL/min * History of acute pancreatitis or gallstone disease * Lack of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose monitoring index and Time in range | From enrollment to 6 months | Achievement of glycemic targets measured through Continuous Glucose Monitoring Sensor. Glycemic goals were established at: GMI ≤ 7.0% TIR \> 70% (glucose 70-180 mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for prandial insulin in Group 2 (glucose >200 mg/dL in ≥2 measurements over 2 days) | From enrollment to 6 months | — |
| Assessment of body mass index (BMI) | Measurements will be taken at the time of enrollment and again after 6 months | weight and height will be combined to report BMI in kg/m\^2 |
| Patient satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire | From enrollment to 6 months | Treatment Satisfaction is rated between 0 and +18, the higher the score the greater the satisfaction with treatment. |
| Number of patients that refused to initiate therapy or discontinued therapy due to personal and/or financial reasons | From enrollment to 6 months | The number of patients that refused to initiate or continue therapy will be measured based on patient's declaration and monthly evaluation. |
Countries
Poland
Outcome results
None listed