The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes
Steroid-Induced Diabetes · Steroid Induced Hyperglycemia
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 60 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Adults ≥ 18 years;
- Male or female;
- Pre-diabetes (HbA1c ≥42 and \<47 mmol/mol, or lifestyle-controlled diabetes (HbA1c ≥48 and ≤52 mmol/mol); measurements within range on two separate occasions ≥90 days apart)
- Body mass index ≥22.5 kg/m2
Exclusion Criteria:
- Prior treatment with any diabetes medication within 90 days;
- Current or planned pregnancy, or current breastfeeding;
- Previous treatment with GC (topical, oral, injected) within 30 days or 90 days for extended-release injected GCs (e.g. Depo-Medrone);
- Continuing requirement for GC treatment (e.g. for steroid replacement, chronic inflammatory or immunological condition);
- Treatment with medications altering DEX pharmacokinetics (e.g. phenytoin, carbamazepine, ritonavir).
- History of pancreatitis, renal disease (eGFR \<30), severe hepatic impairment, gallbladder disorders, or GI disease (e.g. IBD), heart failure, history of medullary thyroid cancer (MTC), or previous skin reactions.
- History of bleeding disorders of anticoagulant therapies (exclusion from the biopsy substudy only)
- History of giving blood or having taken part in another non-related study in the last three months
- History of any other medical, psychological condition, or use of any medications, which, in the opinion of the investigators, would either interfere with the study or compromise the safety of the participant.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento cuádruple
Once daily semaglutide
Once daily semaglutide 3 mg (uptitrated to 3 mg twice daily after two days).
Drug: Semaglutide Oral Product
- Metformin
Metformin modified release tablets (500mg once daily for the first two days, then 500 mg twice daily).
Drug: Metformin Oral Tablet
Placebo
Placebo tablets
Drug: Placebo
Semaglutide Oral Product DRUG
Oral semaglutide 3mg once uptitrated to twice daily
Metformin Oral Tablet DRUG
Metformin modified release tablets 500mg once daily uptitrated to twice daily).
Placebo DRUG
Placebo tablets
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Difference in Glucose tolerance
Plazo: Through study completion, on day 7 dexamethasone and study medication
Glucose tolerance as measured by glucose area under the curve (AUC), in response to standardised mixed meal test (MMT) lasting for 240 minutes. This will be measured in all participants at baseline and at the end of the study medication period (after 7 days of dexamethasone and study medication).
Medidas secundarias
Difference in insulin secretion
Plazo: Day 6 of dexamethasone and study medication
This will be measured by the acute insulin response to glucose based on the incremental AUC for insulin during the first 10 minutes of an IVGTT and the second phase insulin response based on incremental AUC for insulin during +10 to +60 minutes.
This will be measured in a subset of patients (10 from each randomisation group), performed at baseline and on day 6 of dexamethasone and study medication
Difference in insulin sensitivity
Plazo: Day 6
This will be measured by the M value, based on the glucose infusion rate during the last 60 minutes of a hyperinsulinaemic-euglycaemic clamp.
This will be measured in a subset of patients (10 from each randomisation group), performed at baseline and on day 6 of dexamethasone and study medication
Difference in insulin sensitivity
Plazo: Day 6
This will be measured by the M/I index, calculated by the M value divided by the mean steady state insulin levels during the last 60 minutes of a hyperinsulinaemic-euglycaemic clamp.
This will be measured in a subset of patients (10 from each randomisation group), performed at baseline and on day 6 of dexamethasone and study medication
Difference in insulin sensitivity
Plazo: Day 6
This will be measured by the disposition index. This will be calculated as the product of the AIRg and M value during the combined IVGTT and hyperinsulinaemic-euglycaemic clamp.
This will be measured in a subset of patients (10 from each randomisation group), performed at baseline and on day 6 of dexamethasone and study medication.
Otras medidas
Mean glucose and glycaemic variation by continuous glucose monitoring (CGM), using a validated blinded system (Dexcom G7).
Plazo: Through study completion
A baseline recording will be made for 10 days prior to DEX. A second 10-day recording will be made covering the 7 days of DEX and for 3 days after.
Changes in fasting gut hormones
Plazo: Through study completion, on day 7 dexamethasone and study medication
Fasting glucose will be measured at baseline and after a 7-day course of DEX and treatment intervention.
Changes in fasting gut hormones
Plazo: Through study completion, on day 7 dexamethasone and study medication
Fasting insulin and c-peptide levels will be measured at baseline and after a 7-day course of DEX and treatment intervention.
Changes in fasting gut hormones
Plazo: Through study completion, on day 7 dexamethasone and study medication
Fasting glucagon levels will be measured at baseline and after a 7-day course of DEX and treatment intervention.
Changes in fasting lipid profile
Plazo: Through study completion, on day 7 dexamethasone and study medication
Fasting lipid profiles will be measured at baseline and after a 7-day course of DEX and treatment intervention.
Changes in post prandial gut hormones
Plazo: Through study completion, on day 7 dexamethasone and study medication
Post prandial insulin and c-peptide levels will be measured during the mixed meal test, performed at baseline and after a 7-day course of DEX and treatment intervention.
Changes in post prandial gut hormones
Plazo: Through study completion, on day 7 dexamethasone and study medication
Post prandial glucagon levels will be measured during the mixed meal test, performed at baseline and after a 7-day course of DEX and treatment intervention.
Changes in anthropometrics
Plazo: Through study completion, on day 7 dexamethasone and study medication
Anthropometric measurements of height and weight will be combined to report BMI kg/m2 before and after a 7-day course of DEX and treatment intervention.
Changes in anthropometrics
Plazo: Through study completion, on day 7 dexamethasone and study medication
Measurements of hip and waist circumference will be combined to calculate the waist:hip ratio before and after a 7-day course of DEX and treatment intervention.
Tissue specific changes in AMPK determined from adipose and muscle biopsies
Plazo: Through study completion, on day 7 dexamethasone and study medication
This will be taken from a subset of approximately 8 individuals in each group prior to, and at the end of a 7 day course of DEX. Depending on emerging data and participant uptake, this may be subject to change.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Imperial College Healthcare NHS TrustLondon, United KingdomReclutando
Equipo y fechas
- Patrocinador principal
- Imperial College London
- Inicio del estudio
- 15 may 2024 Real
- Finalización primaria
- 1 jun 2027 Estimado
- Finalización del estudio
- 1 jun 2027 Estimado
- Primera publicación
- 19 mar 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
How GLP-1 Analogues Prevent Steroid-Induced Diabetes
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026