NCT07395960RecruitingPhase 1/2
The Efficacy and Safety of Metformin Intervention in Elderly Overweight or Obesity With Mild Cognitive Impairment
The Efficacy and Safety of Metformin Intervention in Elderly Overweight or Obesity With Mild Cognitive Impairment by a Single-center, Randomized, Placebo-controlled Interventional Study (Include Elderly Patients With Obesity or Overweight)
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 20 Dec 2025
- Start date
- Sept 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Fudan University
- Diseases
- Obesity
- NCT number
- NCT07395960
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 54
- From Sept 2025 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any hypoglycemic drugs have been used within 8 weeks prior to enrollment
Other illness
- Type 1 diabetes
- History of alcohol or drug addiction
- Severe gastrointestinal diseases, history of gastrointestinal surgery, severe cardiac or pulmonary dysfunction, malignant tumors and other diseases
- There are diseases such as cerebral infarction and vascular dementia
- There are conditions judged by the investigator as being unsuitable for enrollment
Other
- Unable to undergo central nervous system magnetic resonance examination
- 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)
Who the study is looking for
- 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
Age in the registry: 60 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huadong Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.