A review of the effects of whey protein in patients with type 2 diabetes
Design
Clinical trial with control group, with parallel groups, randomized, on 58 patients. https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used for randomization.
Settings and conduct
The researcher will divide the patients into two groups. One group will be given protopin for 3 months in addition to their routine blood sugar control drugs, and the second group will only take routine blood sugar control drugs. After 3 months, the researcher will again measure his fasting blood glucose level, two-hour sugar, HbA1C, triglyceride and cholesterol after his protein.
The target population of this study is patients with type 2 diabetes referred to Shahid Beheshti Hospital in Qom. In this study, patients are randomly divided into two groups for random allocation of samples using the randomized block method with blocks of four (six blocks of four consisting of AABB,ABAB,BBAA,BABA,ABBA,BAAB) from the site https: //www.sealedenvelope.com/simple-randomiser/v1/lists will be used
Participants/Inclusion and exclusion criteria
Inclusion criteria
Type 2 diabetes for the last 5 years - weight 70 to 90 kg
Exit criteria
Fertility, kidney failure, liver failure, chronic inflammatory disease
Intervention groups
One group will be given protopin for 3 months in addition to their routine blood sugar control drugs, and the second group will only take routine blood sugar control drugs.
Main outcome variables
Decreased blood sugar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240528061925N1
Registration date:2024-08-03, 1403/05/13
Registration timing:registered_while_recruiting
Last update:2024-08-03, 1403/05/13
Update count:0
Registration date
2024-08-03, 1403/05/13
Registrant information
Name
Zahrasadat Razaviasl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3616 2651
Email address
zsrazavi69@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-10, 1403/04/20
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effects of whey protein on resistance insulin and blood sugar control in type II DM
Public title
effects of whey protein on resistance insulin and blood sugar control in type II DM
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes for the last 5 years -
weight 70 to 90 kg
The target population of this study is patients with type 2 diabetes referred to Shahid Beheshti Hospital in Qom. In this study, patients are randomly divided into two groups for random allocation of samples using the randomized block method with blocks of four (six blocks of four consisting of AABB,ABAB,BBAA,BABA,ABBA,BAAB) from the site https: //www.sealedenvelope.com/simple-randomiser/v1/lists will be used
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 Qom University of Medical Sciences
Street address
Qom Medical Sciences Research Assistant Building Safashehr St. Qom
City
qom
Province
Ghoum
Postal code
3713649373
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.MUQ.REC.1403.021
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Blood sugar level
Timepoint
3 months
Method of measurement
Blood sugar test
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:In addition to receiving the routine treatment that the control group will also receive, the intervention group will receive protopin for 3 months (1 serving per day) which was purchased and prepared by the researcher.
Category
Treatment - Drugs
2
Description
Control group: Only routine blood sugar control drugs will be taken
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom - Shahid Beheshti Hospital, Qom University of Medical Sciences
Full name of responsible person
Zahra Sadat Razavi asl
Street address
Shahid Beheshti Hospital - Shahid Beheshti St. Qom -
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3616 2651
Email
zsrazavi69@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. Rahim Ali
Street address
Qom Medical Sciences Research Assistant Building Safashehr St. Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3616 2651
Email
zsrazavi69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zahra Sadat Razavi asl
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Qom - Shahid Beheshti Hospital, Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3616 2651
Email
zsrazavi69@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zahra Sadat Razavi asl
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Qom - Shahid Beheshti Hospital, Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3616 2651
Email
zsrazavi69@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zahra Sadat Razavi asl
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Qom - Shahid Beheshti Hospital, Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3616 2651
Email
zsrazavi69@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions by sending an academic email
From where data/document is obtainable
Zahrasadat Razavi Asl
zsrazavi69@yahoo.com
What processes are involved for a request to access data/document