Determining the effect of dipeptidyl peptidase 4 inhibitors in the control and recovery of diabetic patients with SARS-COV2
Design
Randomized clinical trial with control group , sample size: 35 patients and 35 controls
Settings and conduct
This study will be performed as a double-blind, randomized clinical trial with a control group with a sample size of 70 in Golestan Hospital. Patients in the intervention group are given 100 mg of sitagliptin daily (50 mg every 12 hours). sitagliptin tablets at a dose of 50 mg twice a day will be prescribed to the sitagliptin group and the control group will not receive this drug.Standard and supportive treatment will be performed according to the national guidelines of Corona in both groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who have been diagnosed with Covid 19 based on CT scan or PCR.
Patients with fasting blood sugar above 100 at the time of referral, patients with previous diagnosis of diabetes and under treatment
Study and accept consent to participate in the study
Patients over 18 years of age
Exclusion criteria: acute renal failure, chronic renal failure with stage 4,5
Acute and chronic liver failure
History of immunodeficiency diseases, use of immunodeficiency drugs
Pregnancy and breastfeeding
Patients who are admitted to the intensive care unit upon arrival
Patients with contraindications to sitagliptin (pancreatitis and its history, diabetic gastroparesis, history of hypersensitivity to the drug)
Intervention groups
Patients in the intervention group were given 100 mg of sitagliptin daily (50 mg 30<GFR <60 , 50 mg daily ) and is compared with the control group in terms of clinical, vital and laboratory criteria.
Main outcome variables
fever, 02 saturation, dyspnea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200420047147N2
Registration date:2022-03-07, 1400/12/16
Registration timing:prospective
Last update:2022-03-07, 1400/12/16
Update count:0
Registration date
2022-03-07, 1400/12/16
Registrant information
Name
Ahad Zare
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University,Tehr
Country
Iran (Islamic Republic of)
Phone
+98 21 4467 0888
Email address
ahadzareee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-11, 1400/12/20
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of dipeptidyl peptidase 4 inhibitors on the improvement rate and prognosis of diabetic patients with Covid-19
Public title
Study of therapeutic effect of sitagliptin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been diagnosed with Covid 19 based on CT scan or PCR.
Patients with fasting blood sugar above 100 at the time of referral
Patients with previous diagnosis of diabetes and under treatment
Study and accept consent to participate in the study
Patients over 18 years of age
Exclusion criteria:
Acute renal failure, chronic renal failure with stage 4,5
Acute and chronic liver failure
History of immunodeficiency diseases, using immunodeficiency drugs
Pregnancy and breastfeeding
Patients who are admitted to the intensive care unit upon arrival
Patients with contraindications to cytagliptin (pancreatitis and its history, diabetic gastroparesis, history of severe drug allergy)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used in this study. 7blocks including 6 patients and 7 blocks containing 4 patients generated with online website (www.randomizer.org). In each block, half of patients will be assigned to Sitagliptin group and half of patients will be assigned to Control group by random order.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Aja University of Medical Sciences
Street address
West Fatemi St., Shahid Etemadzadeh St., Aja University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-01-06, 1399/10/17
Ethics committee reference number
IR.AJAUMS.REC.1399.200
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
u07.1
ICD-10 code description
COVID-19 ,virus identified
Primary outcomes
1
Description
o2 saturation without mask
Timepoint
Daily
Method of measurement
Thermometer
2
Description
Fasting blood suger
Timepoint
Daily, From admission to discharge time
Method of measurement
Glucometer
3
Description
Covid-19 infection
Timepoint
At the beginning of the hospital admission
Method of measurement
Covid RT-PCR test
4
Description
Disease severity
Timepoint
At the beginning and end of intervention
Method of measurement
Based on protocol and clinical symptoms
5
Description
cbc diff
Timepoint
every other day in between from the beginning of hospitalization until discharge
Method of measurement
labratory
Secondary outcomes
1
Description
Hospitalization duration
Timepoint
discharge time
Method of measurement
clinical record
2
Description
death
Timepoint
at the end of study
Method of measurement
medical record
Intervention groups
1
Description
Intervention group: Diabetic patients with Covid-19 will be given 100 mg of sitgliptin (50 mg every 12 hours, Dr. Abidi Pharmaceuticals, Iran) daily in addition to the medications used to treat Covid 19(approved by the National Committee).and in case of chronic renal failure in stage III & IV ,25 mg every 12 hours .
Category
Treatment - Drugs
2
Description
Control group: Standard and supportive treatment will be prescribed for patients according to the Corona National Committee guidelines (glucocorticoids ± Remdesivir ± tocilizumab ) will be administered