The aim of this study is to determine the effectiveness of trehalose on reducing glycemic indices in patients with diabetes type2
Design
This study has been designed as a randomized, ،triple-blind, placebo-controlled and parallel trial.
Settings and conduct
A total of 40 enrolled patients will be divided into two treatment and control groups (trehalose and sucrose). Patients will be instructed to ingest the preparation (1.65 g twice a day), approximately 3.3 g/day for 3 months (trehalose n=20, placebo n=20). The participants were permitted to prepare the substances for consumption in a variety of ways, such as dissolving them in beverages.
Ghaem Hospital/ Faculty of Medicine/ Faculty of pharmacy
Participants/Inclusion and exclusion criteria
Inclusion criteria: 40 patients (male or female) with non-insulin-dependent diabetes (HbA1C 7-9%) having stable condition
Exclusion Criteria: Patients with any type of insulin-dependent diabetes receiving insulin therapy (also patients participating will be excluded from the study if they need insulin)
Patients with renal dysfunction (eGFR less than 30 ml/min)
Patients with severe liver dysfunction or cirrhosis.
Patients regularly receiving oral or injectable corticosteroids or those who used α-Glucosidase Inhibitors such as acarbose.
Patients who were pregnant or nursing or wished to conceive.
Intervention groups
Patients will be randomly divided into two treatment and control groups, which will be received trehalose and sucrose as intervention/placebo groups, respectively. Enrolled patients will be instructed to ingest the preparation in opaque sachet form (1.65 g twice a day) for 3 months (trehalose n=20, placebo n=20).
Main outcome variables
The primary endpoint: changes in HOMA-IR as an index of insulin resistance. Secondary endpoints include changes in fasting plasma glucose (FPG), insulin, HbA1c, C-peptide and hs-CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130829014521N18
Registration date:2021-03-16, 1399/12/26
Registration timing:prospective
Last update:2021-03-16, 1399/12/26
Update count:0
Registration date
2021-03-16, 1399/12/26
Registrant information
Name
Amirhossein Sahebkar
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 9260
Email address
sahebkara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effects of oral trehalose supplementation on glycemic control in patients with type 2 diabetes
Public title
Trehalose and diabetes type 2
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female patients aged between 35 and 85 years
Patients with non-insulin-dependent diabetes mellitus in a stable condition.
Exclusion criteria:
Patients with type 1, type 2, or secondary diabetes receiving insulin therapy.
Patients with renal dysfunction (eGFR less than 30 ml/min).
Patients with severe liver dysfunction or cirrhosis.
Patients regularly receiving oral or injectable corticosteroids.
Patients who were pregnant or nursing or wished to conceive.
Patients participating in this study will be excluded from the study if they need insulin.
Patients who used α-Glucosidase Inhibitors such as acarbose will be excluded from the study.
Age
From 35 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
This study has been designed as a randomized, triple-blind, placebo-controlled and parallel trial. Simple randomization for allocation and sealed envelope approach would be considered for concealed allocation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study has been designed as triple-blind and persons including participants, care providers, investigators, and outcome assessors, keeping unaware of the treatment administered, moreover, drug and placebo vials have similar packaging and labeling.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of National institute for medical research development
Street address
No. 21, west Fatemi Ave, Besat Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1419693111
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.NIMAD.REC.1399.267
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11. 9
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
HOMA-IR alterations
Timepoint
At the beginning and end of the intervention trial (Day 0 and week 12)
Method of measurement
HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5
Secondary outcomes
1
Description
fasting plasma glucose (FPG)
Timepoint
Baseline and week 12
Method of measurement
Enzymatic assay
2
Description
Fasting insulin
Timepoint
Baseline and week 12
Method of measurement
Immunoassay
3
Description
HbA1c
Timepoint
Baseline and week 12
Method of measurement
chromatography
4
Description
C peptide
Timepoint
Baseline and week 12
Method of measurement
Immunoassay
5
Description
hs-CRP
Timepoint
Baseline and week 12
Method of measurement
Turbidimetric
Intervention groups
1
Description
Intervention group: Terhalose (natural disaccharide), 1.65 g twice a day (3.3 g/day) for 3 months, in opaque sachet form
Category
Treatment - Drugs
2
Description
Control group: Sucrose, 1.65 g twice a day (3.3 g/day) for 3 months, in opaque sachet form
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mohammad Ali Yaghoubi
Street address
Ahmadabad Blvd, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9187145785
Phone
+98 51 3840 0000
Fax
Email
Yaghoubima@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Dr. Reza Malekzadeh
Street address
No. 21, West Fatemi Ave, Besat Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1419693111
Phone
+98 21 6693 8037
Fax
+98 21 6690 0920
Email
NIMAD@RESEARCH.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Sahebkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, East door of Ferdowsi University, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 1882 9260
Fax
+98 51 1882 3251
Email
sahebkara@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Sahebkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, East door of Ferdowsi University, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 1882 9260
Fax
+98 51 1882 3251
Email
sahebkara@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Sahebkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, East door of Ferdowsi University, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 1882 9260
Fax
+98 51 1882 3251
Email
sahebkara@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD