Actively Recruiting
The Efficacy and Safety of Metformin Intervention in Elderly Overweight or Obesity With Mild Cognitive Impairment
Led by Fudan University · Updated on 2026-02-09
54
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy and Safety of Metformin Intervention in Elderly Overweight or Obesity With Mild Cognitive Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 60 and 75 years old
- Body Mass Index greater than or equal to 24 kg/m2
- Glycated Hemoglobin less than 8.5%
- Montreal Cognitive Assessment Scale score between 20-26 points (if education more than 10 years) or 20-25 points (if education 10 years or less)
- Signed informed consent form
You will not qualify if you...
- Use of any hypoglycemic drugs within 8 weeks before enrollment
- Diagnosis of type 1 diabetes
- Unable to undergo central nervous system magnetic resonance imaging
- History of alcohol or drug addiction
- Severe gastrointestinal diseases, past gastrointestinal surgery, severe heart or lung dysfunction, malignant tumors, or other serious diseases
- Abnormal liver function (liver enzymes more than 2.5 times the upper limit) or abnormal kidney function (glomerular filtration rate less than 45 ml/min)
- Diseases such as cerebral infarction or vascular dementia
- Any condition judged by the investigator to be unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Huadong Hospital, Fudan University
Shanghai, China, 200040
Actively Recruiting
Research Team
X
Xiaoming Tao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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