Efficacy Comparison of Polyethylene Glycol Loxenatide and Gliclazide on the Brain Function in T2DM Patients

NCT06217887 | Unknown

• 1 other identifier: z-2017-26-1902
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, open label, parallel,4-month study to explore and evaluate the therapeutic effects of polyethylene glycol loxenatide on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with normal cognitive status or MCI.

Conditions

Type 2 Diabetes Mellitus; Cognitive Function Abnormal

Keywords

Functional MRI; Cognition; Olfactory function; loxenatide

Outcome Measures

Primary Outcomes (1)

• Change of olfactory brain activation by fMRI

  Whether the activation degree of olfactory task fMRI brain area in the two groups after intervention was different from that before treatment and the difference of changes between the two groups. All patients underwent odor-induced task fMRI on a 3.0T MR scanner with 222 volumes for task fMRI and 230 volumes for resting-state fMRI. The odor-induced task consisted of "fresh air" "rest" and "scent". Odor-induced brain activation was assessed by a general linear model using Statistical Parametric Mapping 12 (SPM12) software. Following extraction of the three separate conditions "fresh air," "scent," and "rest" from the whole sequence, contrasts were made for each participant between "fresh air \> rest" and "scent \> rest." Odor-induced fMRI data were analyzed in the mask of the olfactory network, including the regions of bilateral parahippocampus, amygdala, piriform cortex, insula, orbitofrontal cortex, hippocampus, and entorhinal cortices.

  from baseline to 4-month follow-up

Secondary Outcomes (2)

• Change of cognitive function

  from baseline to 4-month follow-up

• Change of metabolism

  from baseline to 4-month follow-up

Study Arms (2)

loxenatide Group

EXPERIMENTAL

loxenatide will be initiated and maintained at 0.2mg once weekly until the completion of the study. Meanwhile, all patients will also continue on their existing dose and regimen of metformin throughout the study. Visits at 4-week intervals will be performed to evaluate the safety of drugs. Metformin dose can be reduced in response to hypoglycaemia, but loxenatide could not be adjusted. If the plasma glucose still not achieve the target at the maximum dose, the maximum dose will be maintained until the completion of the study.

Drug: loxenatide Group

Gliclazide Group

EXPERIMENTAL

Gliclazide will be initiated and maintained at 30mg/ day every morning until the completion of the study. Meanwhile, all patients will also continue on their existing dose and regimen of metformin throughout the study. Visits at 4-week intervals will be performed to evaluate the safety of drugs. Metformin dose can be reduced in response to hypoglycaemia, but Gliclazide could not be adjusted. If the plasma glucose still not achieve the target at the maximum dose, the maximum dose will be maintained until the completion of the study.

Drug: Gliclazide Group

Interventions

loxenatide Group DRUG

Loxenatide will be initiated and maintained at 0.2mg once weekly until the completion of the study. All patients will also continue on their existing dose and regimen of metformin throughout the study.

Also known as: metformin

loxenatide Group

Gliclazide Group DRUG

Gliclazide will be initiated and maintained at 30mg/day every morning. If necessary, the dose can be increased to 120mg once daily. All patients will also continue on their existing dose and regimen of metformin throughout the study.

Also known as: metformin

Gliclazide Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with type 2 diabetes mellitus ;
• Aged:40 -75 years ;
• Cognitive function assessment suggests normal status or mild cognitive impairment;
• a stable dose of metformin monotherapy (≥1,500 mg daily) for at least 90 days,
• HbA1c 7 - 10%;
• ≥6 years of education;
• Right-handed.

You may not qualify if:

• patients unable to complete brain MRI scanning;
• nasal disease that affected olfactory function;
• hepatic dysfunction with liver transaminases \> 2.5 times upper normal limits and renal impairment with an estimated glomerular filtration rate \< 60ml/min/1.73m2 ;
• acute cardio/cerebrovascular disease, psychiatric disorders, pancreatitis, acute infection, malignant tumor,thyroid disease and homorne drug use;
• a history of related drug allergy;
• alcohol or drug misuse;
• pregnant, breast-feeding or intending to become pregnant.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (2)

• Zhang Z, Zhang B, Wang X, Zhang X, Yang QX, Qing Z, Zhang W, Zhu D, Bi Y. Olfactory Dysfunction Mediates Adiposity in Cognitive Impairment of Type 2 Diabetes: Insights From Clinical and Functional Neuroimaging Studies. Diabetes Care. 2019 Jul;42(7):1274-1283. doi: 10.2337/dc18-2584. Epub 2019 May 21.

  PMID: 31221697 BACKGROUND

• Cheng H, Zhang Z, Zhang B, Zhang W, Wang J, Ni W, Miao Y, Liu J, Bi Y. Enhancement of Impaired Olfactory Neural Activation and Cognitive Capacity by Liraglutide, but Not Dapagliflozin or Acarbose, in Patients With Type 2 Diabetes: A 16-Week Randomized Parallel Comparative Study. Diabetes Care. 2022 May 1;45(5):1201-1210. doi: 10.2337/dc21-2064.

  PMID: 35263425 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cognition Disorders

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Yan Bi, MD, PhD

CONTACT

86-25-83-105302; biyan@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 23, 2024
• Study Start: May 10, 2020
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

CN (1)