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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)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Huadong Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Xiaoming Tao
t983166@163.com
+8613042190822
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 54
Treatments
Experimental: metformin
The intervention group was administered metformin sustained-release tablets (taken once daily, 1500mg each time; if intolerable, the dosage was reduced to the maximum tolerated dose).
No_intervention: control
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov