Overview
Tab Title Description
Tipo de estudio
InterventionalDescribe la naturaleza de un estudio clínico. Los tipos incluyen los siguientes:
- Estudio observacional, en el que se observan personas y se miden los resultados sin afectarlos.
- Estudio intervencionista (ensayo clínico), en el que se estudian nuevos exámenes, tratamientos, medicamentos, procedimientos quirúrgicos o dispositivos.
- Las investigaciones basadas en expedientes médicos utilizan la información histórica recopilada a partir de los registros médicos de grandes grupos de personas para estudiar cómo evolucionan las enfermedades y qué tratamientos y cirugías son más eficaces.
Fase del estudio
2Durante las fases tempranas (fases 1 y 2), los investigadores evalúan la seguridad, los efectos secundarios, las dosis óptimas y los riesgos y beneficios. En la última fase (fase 3), los investigadores estudian si el tratamiento es más eficaz que la terapia estándar actual. Además, comparan la seguridad del nuevo tratamiento con la de los tratamientos actuales. Los ensayos de fase 3 incluyen grandes cantidades de personas para garantizar que el resultado sea válido. También existen la fase muy temprana (fase 0) y la fase posterior (fase 4), aunque son menos comunes. Los ensayos de fase 0 son ensayos pequeños que ayudan a los investigadores a decidir si un nuevo agente debe probarse en un ensayo de fase 1. Los ensayos de fase 4 examinan la seguridad y la eficacia a largo plazo, una vez que un nuevo tratamiento se ha aprobado y está disponible en el mercado.
Identificaciones del estudio
Comité de revisión institucional de la sede
- Rochester, Minnesota: 18-004012
Identificación de NCT (National Clinic Trial, Ensayo Clínico Nacional): NCT03733132
Número de protocolo de patrocinador: 18-004012
Información sobre este estudio
The purpose of this study is to better understand the link between insulin resistance and dementia. Earlier studies have shown that people with insulin resistance are two to four times more likely to develop Alzheimer’s disease and other dementias. Other studies have shown a link between the drug Metformin (the most widely used medication to treat prediabetes and type 2 diabetes) and a reduction in the development of dementia.
The aim of this study is to investigate if 40 weeks of Metformin treatment (in people 60+ years) enhances brain function and how brain function interacts with the body’s metabolism in people with insulin resistance and in people without insulin resistance.
Insulin is a hormone produced by the pancreas that deals with sugar (glucose) in the blood. When we eat food, blood sugar levels increase, and the pancreas produces more insulin to keep blood sugar levels stable. If blood sugar decreases, then insulin levels decrease. If the body becomes resistant to insulin, then the body requires more insulin to balance out blood sugar levels. If this continues, eventually the pancreas is not able to produce the amount of insulin needed to balance out blood sugar leading to an elevated fasting blood sugar (fasting blood glucose value greater than 100 mg/dL). Insulin resistance is a primary risk factor for developing type 2 diabetes, heart disease, and dementia.
This study is recruiting two groups of people: people with insulin resistance and people without insulin resistance. To qualify for the insulin resistance group, a person would need to have an elevated fasting blood sugar test between 100mg/dL and 140mg/dL. To qualify for the non-insulin resistant group a person would need a blood sugar under 95mg/dL.
In people with insulin resistance the study will be measuring changes in brain functions, cognitive ability, and body’s metabolism. These series of tests are performed twice, once before and once after 40 weeks of taking Metformin. Brain functions are measured through a series of brain scans. Cognitive ability is measured using computerized tests. To measure the body’s metabolism, we measure insulin resistance during an overnight stay, blood tests to measure biomarkers, capacity for exercise, body composition scans, and muscle will be assessed from needle muscle biopsies.
In people without insulin resistance, the study will be collecting baseline measurements on brain function, cognitive ability, and body’s metabolism. These tests are performed once. Brain functions are measured through a series of brain scans. Cognitive ability is measured using computerized tests. To measure the body’s metabolism, we measure insulin resistance during an overnight stay, blood tests to measure biomarkers, and a body composition scan.
Remuneration and a travel reimbursement are provided.
Elegibilidad para la participación
Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
To be eligible for the study, a subject must be willing to be randomized and be retained in the study for its duration and meet the following criteria:
- Age ≥ 60 years.
- BMI ≥ 25 kg/m^2.
- Fasting glucose ≥ 100-140 mg/dL.
- Non-smoker.
- English language proficiency.
Exclusion Criteria:
The presence of any of the following is an exclusion for the study:
- Active coronary artery disease or heart failure.
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- Inpatient psychiatric treatment in the past 6 months;
- Use of insulins
- Type 1 diabetes
- Presence of a known and active adrenal disorder;
- Abnormal liver function test results (Transaminase > 2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function;
- Abnormal renal function test results (calculated GFR < 60 mL/min/1.73m^2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty;
- Active gastroparesis;
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study;
- Uncontrolled thyroid disease (TSH undetectable or > 10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise;
- Abuse of alcohol or recreational drugs;
- Infectious process not anticipated to resolve prior to study procedures (e.g., meningitis, pneumonia, osteomyelitis);
- Uncontrolled arterial hypertension (resting diastolic blood pressure > 90 mmHg and/or systolic blood pressure >160 mmHg) at the time of screening;
- Oral steroids;
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol;
- Any metal in the body that could interfere with magnetic resonance imaging (MRI) including pacemaker or implanted defibrillator, neurostimulators, ear implants, metal fragments within the body, metal joints, rods, pins, plates or screws.
- Subjects without English proficiency.
Recruitment for Non-Insulin Resistant Participants
To be eligible for the study, a subject must be willing to be randomized and be retained in the study for its duration and meet the following criteria:
- Age ≥ 60 years.
- 27kg/m^2 ≥ BMI
- 95 mg/dL ≥ Fasting glucose
- Non-smoker.
- English language proficiency.
Exclusion Criteria:
The presence of any of the following is an exclusion for the study:
- Active coronary artery disease or heart failure.
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- Inpatient psychiatric treatment in the past 6 months;
- Presence of a known and active adrenal disorder.
- Type 1 diabetes
- Abnormal liver function test results (Transaminase > 2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function;
- Abnormal renal function test results (calculated GFR < 60 mL/min/1.73m^2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty;
- Active gastroparesis;
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study;
- Uncontrolled thyroid disease (TSH undetectable or > 10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise;
- Abuse of alcohol or recreational drugs;
- Infectious process not anticipated to resolve prior to study procedures (e.g., meningitis, pneumonia, osteomyelitis);
- Uncontrolled arterial hypertension (resting diastolic blood pressure > 90 mmHg and/or systolic blood pressure >160 mmHg) at the time of screening;
- Oral steroids;
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol;
- Any metal in the body that could interfere with magnetic resonance imaging (MRI) including pacemaker or implanted defibrillator, neurostimulators, ear implants, metal fragments within the body, metal joints, rods, pins, plates or screws.
- Subjects without English proficiency.
Eligibility last updated 8/26/21. Questions regarding updates should be directed to the study team contact.