Clinical trial

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

Recruiting now · Phase 1, Phase 2 · 1 countries · Registry ID NCT07395960

Recruiting nowPhase 1, Phase 2Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age60 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionMild Cognitive Impairment, Overweight or Obesity, Elderly

Full registry criteria

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

Treatments and study arms

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).

Primary outcomes

fMRI26 weeks

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Huadong Hospital, Fudan University🇨🇳 Shanghai, China

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Xiaoming TaoContact

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