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

NCTNCT06461377Other id2023-SR-611

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Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 50 participants (estimated)
Sponsor: The First Affiliated Hospital with Nanjing Medical University · Other
Design: Randomized · Single masking
Countries: 1 country
China
Start: 13 Jun 2024
Primary completion: 31 Dec 2026 (estimated)
Completion: 31 Dec 2027 (estimated)
First posted: 17 Jun 2024
Last update posted: 21 Jun 2024
Conditions: Type 2 Diabetes · Diabetes With Diabetic Autonomic Neuropathy (Diagnosis)

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20242025202620272028

Ph 4
The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy
NCT06461377
13 Jun 2024 to est. 31 Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Glucagon-like peptide-1 receptor agonist：SemaglutideDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

heart rate variability（HRV）
Time frame · baseline and 12 weeks later
Registry description
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(19)

E/I difference
Time frame · basline and 12 weeks later
Registry description
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
30/15 ratio
Time frame · basline and 12 weeks later
Registry description
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
Valsalva action
Time frame · basline and 12 weeks later
Registry description
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
the difference between lying and Orthostatic blood pressure
Time frame · basline and 12 weeks later
Registry description
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
grip strength tests
Time frame · basline and 12 weeks later
Registry description
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
BMI
Time frame · basline and 12 weeks later
Registry description
It is calculated by dividing a person's weight in kg by their height in meters squared
FBG
Time frame · basline and 12 weeks later
Registry description
Fasting glucose
Fins
Time frame · basline and 12 weeks later
Registry description
Fasting insulin
Fc-peptide
Time frame · basline and 12 weeks later
Registry description
Fasting c-peptide
HOMA-IR
Time frame · basline and 12 weeks later
Registry description
calculated by HOMA Calculator v2.2.3
HbA1c
Time frame · basline and 12 weeks later
Registry description
Reflect the average blood sugar of 3 months
Total cholesterol
Time frame · basline and 12 weeks later
Registry description
one of serum biochemical index
triglyceride
Time frame · basline and 12 weeks later
Registry description
one of serum biochemical index
HDL
Time frame · basline and 12 weeks later
Registry description
high-density lipoprotein，one of serum biochemical index
LDL
Time frame · basline and 12 weeks later
Registry description
low density lipoprotein，one of serum biochemical index
UA
Time frame · basline and 12 weeks later
Registry description
Uric Acid，one of serum biochemical index
creatinine
Time frame · basline and 12 weeks later
Registry description
one of serum biochemical index
eGFR
Time frame · basline and 12 weeks later
Registry description
Estimated glomerular filtration rate，one of serum biochemical index
Urinary trace albumin/urinary creatinine
Time frame · basline and 12 weeks later
Registry description
urine protein test urine protein urine protein test

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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