Metformin Withdrawal In Metabolic Syndrome (METMS)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ricardo Mora-Rodriguez, Prof.
- 전화번호: +34 675424515
- 이메일: Ricardo.Mora@uclm.es
연구 연락처 백업
- 이름: Diego Mora-Gonzalez, Msc.
- 전화번호: +34 634596243
- 이메일: Diego.Mora@uclm.es
연구 장소
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Toledo
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Toledo, Toledo, 스페인, 45071
- 모병
- University of Castilla-La Mancha
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연락하다:
- University Castilla-La Mancha
- 전화번호: +34 925 26 88 00
- 이메일: fisioterapiayenfermeria.to@uclm.es
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: METFOR WITHDRAW
Participants in this arm will stop their Metformin treatment for 14 days.
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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.
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활성 비교기: CONTROL
Participants in this arm will continue with their Metformin treatment for 14 days.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
기간: From enrolment to the end of the intervention, 14 days.
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HOMA-IR will be calculated from fasting plasma glucose and fasting insulin concentrations.
Higher values indicate greater insulin resistance.
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From enrolment to the end of the intervention, 14 days.
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Change in Matsuda Insulin Sensitivity Index
기간: From enrolment to the end of the intervention, 14 days.
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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.
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From enrolment to the end of the intervention, 14 days.
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Mean sensor glucose during the intervention period
기간: From enrolment to the end of the intervention, 14 days.
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Mean glucose concentration will be assessed using continuous glucose monitoring (CGM) during the 14-day intervention period.
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From enrolment to the end of the intervention, 14 days.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in glycated hemoglobin
기간: From enrolment to the end of the intervention, 14 days.
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HbA1c will be measured in blood and reported as percentage of total hemoglobin.
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From enrolment to the end of the intervention, 14 days.
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Percentage of time in range assessed by continuous glucose monitoring
기간: From enrolment to the end of the intervention, 14 days.
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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.
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From enrolment to the end of the intervention, 14 days.
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Change in respiratory exchange ratio response during the oral glucose tolerance test
기간: From enrolment to the end of the intervention, 14 days.
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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.
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From enrolment to the end of the intervention, 14 days.
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Change in plasma triglycerides
기간: From enrolment to the end of the intervention, 14 days.
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Plasma triglyceride concentration will be measured in blood before each OGTT.
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From enrolment to the end of the intervention, 14 days.
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Change in total cholesterol
기간: From enrolment to the end of the intervention, 14 days.
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Total cholesterol concentration will be measured in blood before each OGTT.
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From enrolment to the end of the intervention, 14 days.
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Change in HDL-cholesterol
기간: From enrolment to the end of the intervention, 14 days.
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HDL-cholesterol concentration will be measured in blood before each OGTT.
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From enrolment to the end of the intervention, 14 days.
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Change in LDL-cholesterol
기간: From enrolment to the end of the intervention, 14 days.
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LDL-cholesterol concentration will be measured in blood before each OGTT.
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From enrolment to the end of the intervention, 14 days.
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Change in estimated glomerular filtration rate
기간: From enrolment to the end of the intervention, 14 days.
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The estimated glomerular filtration rate will be calculated from serum creatinine and reported in mL/min/1.73
m².
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From enrolment to the end of the intervention, 14 days.
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Change in serum creatinine
기간: From enrolment to the end of the intervention, 14 days.
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Serum creatinine concentration will be measured in blood before each OGTT.
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From enrolment to the end of the intervention, 14 days.
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Change in urinary albumin-to-creatinine ratio
기간: From enrolment to the end of the intervention, 14 days.
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The urinary albumin-to-creatinine ratio will be measured in urine before each OGTT.
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From enrolment to the end of the intervention, 14 days.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- METMS
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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