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New treatment option for Metabolic Syndrome (MetS)
Official title Metformin Withdrawal In Metabolic Syndrome
ClinicalTrials.gov ID: NCT07659444
What this study is testing
- What it's testing
- The goal of this clinical trial is to investigate how a short-term interruption of metformin treatment affects insulin sensitivity, glucose control, and metabolic flexibility in adults with metabolic syndrome who are taking metformin as part of their usual medical treatment. Temporary interruptions in metformin treatment may occur in real-life situations, such as missed doses, medication access problems, travel, or planned short-term discontinuation for clinical reasons.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Uncontrolled diabetes or clinically unsafe glycemic status at screening, defined as HbA1c above 8.0 %, fasting plasma glucose above 160 mg/dl, or any...
- Known allergy or intolerance to materials used in the continuous glucose monitoring device, adhesive patches, venous catheter, or study procedures.
See the full eligibility 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...
- 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...
- No previous history of clinically significant diabetes-related complications, including diabetic retinopathy, diabetic foot disease, severe peripheral neuropathy, or diabetic kidney disease.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toledo, Toledo, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toledo, Toledo, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.