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

NCT07395960 | Recruiting Phase 1

• 1 other identifier: 2025K299
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment; Overweight or Obesity; Elderly

Outcome Measures

Primary Outcomes (1)

• fMRI

  The insulin sensitivity of the central nervous system in the two groups of subjects before and after treatment is evaluated by nasal inhalation of insulin combined with fMRI.

  26 weeks

Secondary Outcomes (1)

• Montreal Cognitive Assessment Scale (Moca scale)

  26 weeks

Other Outcomes (6)

• body composition

  26 weeks

• grip strength

  26 weeks

• glycated hemoglobin

  26 weeks

Study Arms (2)

metformin

EXPERIMENTAL

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).

Drug: Metfomin

control

NO INTERVENTION

Interventions

Metfomin DRUG

The intervention group is administered metformin sustained-release tablets (taken once daily, 1500mg each time; if intolerable, the dosage was reduced to the maximum tolerated dose).

metformin

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong Hospital, Fudan University

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Overweight; Obesity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoming Tao

  Huadong Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaoming Tao

CONTACT

+8613042190822; t983166@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: February 9, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)