RecruitingPhase 1/2

The Efficacy and Safety of Metformin Intervention in Elderly Overweight or Obesity With Mild Cognitive Impairment

China54 participantsStarted 2025-09-01

Plain-language summary

The prevalence of cognitive impairment in elderly obese patients is high, and the burden on families and society is heavy. Early intervention for mild cognitive impairment (MCI) is of great value. Central nervous system insulin resistance plays a role in the pathogenesis of cognitive impairment, and functional magnetic resonance imaging(fMRI) can evaluate cognitive impairment by observing central insulin resistance. Some large database studies of Type 2 Diabetes show that metformin is related to reducing the risk of dementia, but some studies have different conclusions, and there is few related study in elderly obese patients. The investigators speculate that metformin may improve cognitive dysfunction by improving central insulin resistance in elderly obese patients. A prospective, randomized controlled single center clinical cohort study will be conducted on 54 elderly obese patients with MCI. One group will receive metformin and lifestyle intervention, while the control group will receive simple lifestyle intervention. All subjects will be followed up for 26 weeks. Medical history collection, physical examination, and laboratory tests will be conducted before and after intervention, and the Montreal Cognitive Assessment Scale will be used for evaluation. Nasal insulin inhalation combined with fMRI will be used to evaluate central insulin resistance status as an objective basis for cognitive function evaluation. The main purpose of the study is to provide more accurate clinical research evidence for the prevention and treatment of MCI in elderly obese patients, in order to reduce the risk of developing dementia and alleviate the burden on families and society.

Who can participate

Age range

60 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 60 - 75 years old * Body Mass Index: ≥ 24 kg/m2 * Glycated Hemoglobin \< 8.5% * Moca Scale score: 20-26 points (education\> 10 years) or 20-25 points (education≤ 10 years) * Sign the informed consent form Exclusion Criteria: * Any hypoglycemic drugs have been used within 8 weeks prior to enrollment * Type 1 diabetes * Unable to undergo central nervous system magnetic resonance examination * History of alcohol or drug addiction * Severe gastrointestinal diseases, history of gastrointestinal surgery, severe cardiac or pulmonary dysfunction, malignant tumors and other diseases * Abnormal liver function (liver enzyme indicators more than 2.5 times the upper limit of the reference range) or abnormal kidney function (estimated glomerular filtration rate\< 45 ml/min) * There are diseases such as cerebral infarction and vascular dementia * There are conditions judged by the investigator as being unsuitable for enrollment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

fMRI

Timeframe: 26 weeks

Trial details

NCT IDNCT07395960

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Xiaoming Tao

+8613042190822 t983166@163.com

View on ClinicalTrials.gov More Mild Cognitive Impairment trials