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Metformin Withdrawal In Metabolic Syndrome (METMS)

16 giugno 2026 aggiornato da: University of Castilla-La Mancha

Effects of 14-Day Metformin Withdrawal on OGTT-Derived Insulin Sensitivity in Adults With Metabolic Syndrome: A Randomized Controlled Trial

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. This study aims to understand whether stopping metformin for 14 days leads to rapid changes in glucose metabolism or whether the effects of previous metformin treatment may persist during a short period without the medication.

The main questions it aims to answer are:

Does stopping metformin for 14 days worsen glucose control or insulin sensitivity measured by oral glucose tolerance tests, HbA1c, and continuous glucose monitoring?

Does stopping metformin for 14 days affect metabolic flexibility, measured by indirect calorimetry during the oral glucose tolerance test?

Does stopping metformin for 14 days affect blood lipids, liver and inflammatory markers, red blood cell parameters, kidney function markers, fasting lactate levels, blood pressure, or heart rate?

Researchers will compare participants who stop metformin for 14 days with participants who continue their usual metformin treatment to see whether temporary metformin discontinuation affects insulin sensitivity, glucose control, metabolic flexibility, and other cardiometabolic markers.

Participants in the metformin discontinuation group will stop taking metformin for 14 days. They will attend study visits on day 0, day 4, day 7, and day 14. At each visit, they will complete an oral glucose tolerance test, have blood samples taken, and undergo indirect calorimetry measurements before and after the glucose drink. Blood pressure and heart rate will also be measured during the test. Participants will wear a continuous glucose monitor throughout the 14-day period to track glucose levels and help detect any potentially unsafe increase in blood glucose.

Participants in the usual-treatment group will continue taking metformin as prescribed. They will attend study visits on day 0 and day 14. At each visit, they will complete an oral glucose tolerance test, have blood samples taken, and undergo indirect calorimetry, blood pressure, and heart rate measurements during the test.

At the study visits, researchers will assess glucose and insulin responses, HbA1c, continuous glucose monitoring data, metabolic flexibility, blood lipid profile, liver and inflammatory markers, red blood cell parameters, kidney function markers, fasting lactate levels, blood pressure, and heart rate.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

28

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Diego Mora-Gonzalez, Msc.
  • Numero di telefono: +34 634596243
  • Email: Diego.Mora@uclm.es

Luoghi di studio

  • Spagna
    • Toledo
      • Toledo, Toledo, Spagna, 45071

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: METFOR WITHDRAW
Participants in this arm will stop their Metformin treatment for 14 days.
Comportamentale: Temporary Metformin Withdrawal
Participants assigned to this intervention will temporarily stop taking their usual metformin treatment for 14 days. During this period, participants will undergo oral glucose tolerance tests and blood sampling on day 0, day 4, day 7, and day 14. They will also wear a continuous glucose monitoring device throughout the 14-day period to monitor glucose levels during metformin discontinuation.
Comparatore attivo: CONTROL
Participants in this arm will continue with their Metformin treatment for 14 days.
Comportamentale: Temporary Metformin Withdrawal
Participants assigned to this intervention will temporarily stop taking their usual metformin treatment for 14 days. During this period, participants will undergo oral glucose tolerance tests and blood sampling on day 0, day 4, day 7, and day 14. They will also wear a continuous glucose monitoring device throughout the 14-day period to monitor glucose levels during metformin discontinuation.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
HOMA-IR will be calculated from fasting plasma glucose and fasting insulin concentrations. Higher values indicate greater insulin resistance.
From enrolment to the end of the intervention, 14 days.
Change in Matsuda Insulin Sensitivity Index
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
The Matsuda Insulin Sensitivity Index will be calculated from glucose and insulin concentrations obtained during the oral glucose tolerance test. Higher values indicate greater whole-body insulin sensitivity.
From enrolment to the end of the intervention, 14 days.
Mean sensor glucose during the intervention period
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
Mean glucose concentration will be assessed using continuous glucose monitoring (CGM) during the 14-day intervention period.
From enrolment to the end of the intervention, 14 days.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in glycated hemoglobin
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
HbA1c will be measured in blood and reported as percentage of total hemoglobin.
From enrolment to the end of the intervention, 14 days.
Percentage of time in range assessed by continuous glucose monitoring
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
Time in range will be defined as the percentage of time with sensor glucose between 70 and 180 mg/dL during the 14-day intervention period.
From enrolment to the end of the intervention, 14 days.
Change in respiratory exchange ratio response during the oral glucose tolerance test
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
Respiratory exchange ratio (RER) will be assessed by indirect calorimetry during the oral glucose tolerance test. The response will be calculated using the pre-specified respiratory exchange ratio values obtained during the test.
From enrolment to the end of the intervention, 14 days.
Change in plasma triglycerides
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
Plasma triglyceride concentration will be measured in blood before each OGTT.
From enrolment to the end of the intervention, 14 days.
Change in total cholesterol
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
Total cholesterol concentration will be measured in blood before each OGTT.
From enrolment to the end of the intervention, 14 days.
Change in HDL-cholesterol
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
HDL-cholesterol concentration will be measured in blood before each OGTT.
From enrolment to the end of the intervention, 14 days.
Change in LDL-cholesterol
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
LDL-cholesterol concentration will be measured in blood before each OGTT.
From enrolment to the end of the intervention, 14 days.
Change in estimated glomerular filtration rate
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
The estimated glomerular filtration rate will be calculated from serum creatinine and reported in mL/min/1.73 m².
From enrolment to the end of the intervention, 14 days.
Change in serum creatinine
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
Serum creatinine concentration will be measured in blood before each OGTT.
From enrolment to the end of the intervention, 14 days.
Change in urinary albumin-to-creatinine ratio
Lasso di tempo: From enrolment to the end of the intervention, 14 days.
The urinary albumin-to-creatinine ratio will be measured in urine before each OGTT.
From enrolment to the end of the intervention, 14 days.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Castilla-La Mancha

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 aprile 2026

Completamento primario (Stimato)

30 luglio 2026

Completamento dello studio (Stimato)

30 agosto 2026

Date di iscrizione allo studio

Primo inviato

9 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • METMS

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

Upon reasonable request

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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