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NCT Number: NCT06461377

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes With Diabetic Autonomic Neuropathy (Diagnosis) Disease Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location status: Recruiting

Location contact

li wang

CONTACT

[email protected]

15061040299

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • <18 years old
  • Pregnant or lactating women
  • Acute and chronic pancreatitis
  • Recent acute complications of diabetes
  • Arrhythmia or taking drugs that affect heart rate
  • Thyroid disease
  • Severe organ dysfunction
  • Denial of informed consen

Treatment and study plan

Glucagon-like peptide-1 receptor agonist：Semaglutide

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. FBG

    Time frame: basline and 12 weeks later

    Fasting glucose

  8. Fins

    Time frame: basline and 12 weeks later

    Fasting insulin

  9. Fc-peptide

    Time frame: basline and 12 weeks later

    Fasting c-peptide

  10. HOMA-IR

    Time frame: basline and 12 weeks later

    calculated by HOMA Calculator v2.2.3

  11. HbA1c

    Time frame: basline and 12 weeks later

    Reflect the average blood sugar of 3 months

  12. Total cholesterol

    Time frame: basline and 12 weeks later

    one of serum biochemical index

  13. triglyceride

    Time frame: basline and 12 weeks later

    one of serum biochemical index

  14. HDL

    Time frame: basline and 12 weeks later

    high-density lipoprotein，one of serum biochemical index

  15. LDL

    Time frame: basline and 12 weeks later

    low density lipoprotein，one of serum biochemical index

  16. UA

    Time frame: basline and 12 weeks later

    Uric Acid，one of serum biochemical index

  17. creatinine

    Time frame: basline and 12 weeks later

    one of serum biochemical index

  18. eGFR

    Time frame: basline and 12 weeks later

    Estimated glomerular filtration rate，one of serum biochemical index

  19. Urinary trace albumin/urinary creatinine

    Time frame: basline and 12 weeks later

    urine protein test urine protein urine protein test

Study contacts

Contact information is provided by the study sponsor or research team.

jianbo Li, MD/PhD

CONTACT

[email protected]

13951750648

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 17, 2024
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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