The Efficacy and Safety of Metformin Intervention in Elderly Overweight or Obesity With Mild Cognitive Impairment
Recruiting · NCT07395960 · Interventional (participants receive a specific treatment) · Lead sponsor: Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- Huadong Hospital, Fudan University - Shanghai, China