A Phase 4 interventional study of Glucagon-like peptide-1 receptor agonist：Semaglutide in Type 2 Diabetes and Diabetes With Diabetic Autonomic Neuropathy (Diagnosis), sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 4, Interventional, and Treatment
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 50 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 563 studies on the registry; 311 are open to participants now.
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Exclusion Criteria:
In the control group, no other intervention was used except the basic drugs for diabetes treatment
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
Also known as: Semaglutide
heart rate variability（HRV）
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.
Time frame: baseline and 12 weeks later
E/I difference
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
Time frame: basline and 12 weeks later
30/15 ratio
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
Time frame: basline and 12 weeks later
Valsalva action
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
Time frame: basline and 12 weeks later
the difference between lying and Orthostatic blood pressure
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
Time frame: basline and 12 weeks later
grip strength tests
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
Time frame: basline and 12 weeks later
BMI
It is calculated by dividing a person's weight in kg by their height in meters squared
Time frame: basline and 12 weeks later
FBG
Fasting glucose
Time frame: basline and 12 weeks later
Fins
Fasting insulin
Time frame: basline and 12 weeks later
Fc-peptide
Fasting c-peptide
Time frame: basline and 12 weeks later
HOMA-IR
calculated by HOMA Calculator v2.2.3
Time frame: basline and 12 weeks later
HbA1c
Reflect the average blood sugar of 3 months
Time frame: basline and 12 weeks later
Total cholesterol
one of serum biochemical index
Time frame: basline and 12 weeks later
triglyceride
one of serum biochemical index
Time frame: basline and 12 weeks later
HDL
high-density lipoprotein，one of serum biochemical index
Time frame: basline and 12 weeks later
LDL
low density lipoprotein，one of serum biochemical index
Time frame: basline and 12 weeks later
UA
Uric Acid，one of serum biochemical index
Time frame: basline and 12 weeks later
creatinine
one of serum biochemical index
Time frame: basline and 12 weeks later
eGFR
Estimated glomerular filtration rate，one of serum biochemical index
Time frame: basline and 12 weeks later
Urinary trace albumin/urinary creatinine
urine protein test urine protein urine protein test
Time frame: basline and 12 weeks later
Started Jun 2024 (actual). Primary completion is estimated for Dec 2026, 30 months after the start.
Of 311 non-industry phase 4 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's planned 30 months is close to that.
Counting every sponsor, half of 440 studies reached it within 23 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Semaglutide
The First Affiliated Hospital with Nanjing Medical University →