Metformin Withdrawal In Metabolic Syndrome
Sponsored by University of Castilla-La Mancha
About this trial
Last updated 4 months ago
Study ID
Status
RecruitingType
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started Apr 2026
What is this trial about?
What are the participation requirements?
Inclusion Criteria
* Currently treated with metformin as part of their usual medical care for at least 12 months before enrolment.
* Diagnosis of metabolic syndrome according to established clinical criteria, based on the presence of at least three of the following components: increased waist circumference, elevated triglycerides, reduced HDL cholesterol, elevated blood pressure or antihypertensive treatment, and elevated fasting glucose or treatment for dysglycemia.
* Stable metformin dose for at least 3 months before enrolment.
* Willing and medically able to temporarily discontinue metformin for 14 days if assigned to the metformin discontinuation group.
* Able and willing to undergo repeated oral glucose tolerance tests, venous catheter placement, repeated blood sampling, indirect calorimetry measurements, blood pressure measurements, and heart rate measurements.
* willing to wear a continuous glucose monitoring device during the study period.
* Preserved kidney function at baseline, defined as estimated glomerular filtration rate ≥60 mL/min/1.75 m² and urine albumin-to-creatinine ratio <30 mg/g, or values considered clinically acceptable by the study physician.
* No previous history of clinically significant diabetes-related complications, including diabetic retinopathy, diabetic foot disease, severe peripheral neuropathy, or diabetic kidney disease.
Exclusion Criteria
* Diagnosis of type 1 diabetes.
* Current treatment with insulin or other glucose-lowering medications.
* Previous history of severe hypoglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemic state, or other acute diabetes-related metabolic complications.
* Uncontrolled diabetes or clinically unsafe glycemic status at screening, defined as HbA1c above 8.0 %, fasting plasma glucose above 160 mg/dl, or any other glycemic value considered unsafe by the study physician.
* Known allergy or intolerance to materials used in the continuous glucose monitoring device, adhesive patches, venous catheter, or study procedures.
