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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age60-75
SponsorFudan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: metforminExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

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.

Time frame
26 weeks

Secondary outcomes

1

Montreal Cognitive Assessment Scale (Moca scale)

The Moca scale score ranges from 0 to 30. The higher the score, the better the cognitive function. The Moca scale score for mild cognitive impairment ranges from 20 to 26 points (for those with more than 10 years of education) or 20 to 25 points (for those with 10 years or less of education). The investigators compare the scores of the Moca scale before and after the intervention.

Time frame
26 weeks

Other outcomes

1

body composition

The body composition is measured using Beijing Yueqi BIA. The indicators include weight (kg), skeletal muscle (kg), body fat (kg), body mass index (kg/m2), body fat percentage (%), visceral fat area (cm2), waist-to-hip ratio, and skeletal muscle index (kg/m2). The investigators compare the changes in body composition before and after the intervention.

Time frame
26 weeks
2

grip strength

The grip strength is evaluated using an electronic grip strength tester. Each hand is tested twice, and the average values are taken. The side with the greater grip strength is selected as the final grip strength. A low grip strength is defined as less than 28 kg for men and less than 18 kg for women. The investigators compare the changes in grip strength before and after the intervention.

Time frame
26 weeks
3

glycated hemoglobin

The glycated hemoglobin (%) is measured on an empty stomach, and the investigators compare the changes before and after the intervention.

Time frame
26 weeks
4

insulin

The measurement of insulin (mIU/L) is conducted in the fasting state. The investigators compare the changes before and after the intervention.

Time frame
26 weeks

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