The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy

June 19, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University
Diabetic cardiac autonomic neuropathy (DCAN) is a common chronic complication that reduces survival in patients with diabetes. Epidemiological surveys have shown that the prevalence of DCAN is 25-75% in people with type 2 diabetes. The onset of DCAN is insidious and easy to be ignored in the early stage. With the progression of the disease, the following clinical symptoms gradually appear, including reduced heart rate variability, exercise intolerance, resting tachycardia, orthostatic hypotension, painless myocardial infarction and even sudden death, which seriously endanger the life and health of type 2 diabetes patients. Existing literature has shown that glucagon-like peptide-1 receptor agonist (GLP-1RA) can improve diabetic peripheral neuropathy and diabetic cognitive dysfunction, but there are few studies on improving diabetic autonomic neuropathy. Insulin resistance is an important risk factor for DCAN. Patients with type 2 diabetes are characterized by insulin resistance, and GLP-1RA is recognized as a drug to improve insulin resistance and control blood sugar in patients with diabetes. In this study, GLP-1RA was used to intervene patients with type 2 diabetes, and the changes in blood sugar control and insulin resistance status of patients were followed up. Special attention was paid to the improvement of autonomic neuropathy in diabetic patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • 江苏
      • Nanjing, 江苏, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 18-70 years
  2. Patients with T2DM who meet the diagnostic guidelines
  3. The patient signed the relevant informed consent form
  4. Being overweight or obese

Exclusion Criteria:

  1. <18 years old
  2. Pregnant or lactating women
  3. Acute and chronic pancreatitis
  4. Recent acute complications of diabetes
  5. Arrhythmia or taking drugs that affect heart rate
  6. Thyroid disease
  7. Severe organ dysfunction
  8. Denial of informed consen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
In the control group, no other intervention was used except the basic drugs for diabetes treatment
Experimental: GLP-1RA intervention group
Subcutaneous injection of semaglutide 0.5-1mg （dosage depends on individual body weight）once a week (not off-label use)，lasting 12 weeks
Drug: Glucagon-like peptide-1 receptor agonist：Semaglutide
The GLP-1RA intervention group was given subcutaneous injection of GLP-1RA for 3 months, while the control group was not given GLP-1RA intervention
Other Names:
  • Semaglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate variability（HRV）
Time Frame: baseline and 12 weeks later
All participants were given ambulatory electrocardiogram.The time domain analysis and frequency domain analysis of heart rate variability are included in the holter ECG report.
baseline and 12 weeks later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
E/I difference
Time Frame: basline and 12 weeks later
Take an average of 6 deep breaths per minute, record the difference between the maximum heart rate and the minimum heart rate during deep breathing
basline and 12 weeks later
30/15 ratio
Time Frame: basline and 12 weeks later
The heart rate in lying position was measured, and the R-R interval in more than 30 beats was measured after standing, and the ratio between the longest R-R interval in the 25-35 beats and the shortest R-R interval in the 10-15 beats after standing was calculated
basline and 12 weeks later
Valsalva action
Time Frame: basline and 12 weeks later
After deep inhalation, hold your breath as much as possible, and then blow air into the modified sphygmomanometer to keep the pressure of the sphygmomanometer at 40mmHg, continue for 10-15s, and then relax for 1 minute, a total of 3 minutes. At the same time, ECG was recorded to record the ratio of maximum heart rate to minimum heart rate
basline and 12 weeks later
the difference between lying and Orthostatic blood pressure
Time Frame: basline and 12 weeks later
Blood pressure was measured in the supine position. The patient was asked to stand immediately, and blood pressure was measured at the first and fifth minutes
basline and 12 weeks later
grip strength tests
Time Frame: basline and 12 weeks later
First, the basic blood pressure and the maximum grip strength were measured, and the blood pressure was measured after 5 minutes of continuous hard clenching with the grip apparatus (the force used was 30% of the maximum grip strength measured), and the blood pressure difference was calculated
basline and 12 weeks later
BMI
Time Frame: basline and 12 weeks later
It is calculated by dividing a person's weight in kg by their height in meters squared
basline and 12 weeks later
FBG
Time Frame: basline and 12 weeks later
Fasting glucose
basline and 12 weeks later
Fins
Time Frame: basline and 12 weeks later
Fasting insulin
basline and 12 weeks later
Fc-peptide
Time Frame: basline and 12 weeks later
Fasting c-peptide
basline and 12 weeks later
HOMA-IR
Time Frame: basline and 12 weeks later
calculated by HOMA Calculator v2.2.3
basline and 12 weeks later
HbA1c
Time Frame: basline and 12 weeks later
Reflect the average blood sugar of 3 months
basline and 12 weeks later
Total cholesterol
Time Frame: basline and 12 weeks later
one of serum biochemical index
basline and 12 weeks later
triglyceride
Time Frame: basline and 12 weeks later
one of serum biochemical index
basline and 12 weeks later
HDL
Time Frame: basline and 12 weeks later
high-density lipoprotein，one of serum biochemical index
basline and 12 weeks later
LDL
Time Frame: basline and 12 weeks later
low density lipoprotein，one of serum biochemical index
basline and 12 weeks later
UA
Time Frame: basline and 12 weeks later
Uric Acid，one of serum biochemical index
basline and 12 weeks later
creatinine
Time Frame: basline and 12 weeks later
one of serum biochemical index
basline and 12 weeks later
eGFR
Time Frame: basline and 12 weeks later
Estimated glomerular filtration rate，one of serum biochemical index
basline and 12 weeks later
Urinary trace albumin/urinary creatinine
Time Frame: basline and 12 weeks later
urine protein test urine protein urine protein test
basline and 12 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: jianbo Li, MD/PhD, First Affiliated Hospital，Nanjing Medical University，China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-SR-611

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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