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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02917928




Registration number
NCT02917928
Ethics application status
Date submitted
19/09/2016
Date registered
28/09/2016

Titles & IDs
Public title
The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health
Scientific title
The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health in Patients With Prediabetes and Type 2 Diabetes: a Randomsied, Double-blinded, Placebo-controlled Trial
Secondary ID [1] 0 0
16061AI
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor Glycemic Control 0 0
Cardiovascular Risk Factors 0 0
Cognitive Function 1, Social 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - carnosine
Treatment: Drugs - Placebo

Active comparator: Intervention - Each participant will be given a daily oral dose 2 g of carnosine (4 tablets of 500mg each) for 14 weeks

Placebo comparator: Control - Each participant will be given a daily oral dose 2 g of placebo (4 tablets of 500mg each) for 14 weeks


Treatment: Other: carnosine
Each participant will be given a daily oral dose 2 g of carnosine (4 tablets of 500mg each) for 14 weeks

Treatment: Drugs: Placebo
Each participant will be given a daily oral dose 2 g of placebo (4 tablets of 500mg each) for 14 weeks
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Oral Glucose Tolerance Test
Timepoint [1] 0 0
baseline and 14 weeks
Secondary outcome [1] 0 0
Change in HbA1c
Timepoint [1] 0 0
baseline and 14 weeks
Secondary outcome [2] 0 0
Change in lipid profile
Timepoint [2] 0 0
baseline and 14 weeks
Secondary outcome [3] 0 0
Change in systolic and diastolic blood pressure
Timepoint [3] 0 0
baseline and 14 weeks
Secondary outcome [4] 0 0
Change in arterial stiffness and central blood pressure
Timepoint [4] 0 0
baseline and 14 weeks
Secondary outcome [5] 0 0
Change in markers of endothelial dysfunction
Timepoint [5] 0 0
baseline and 14 weeks
Secondary outcome [6] 0 0
Change in heart rate variability
Timepoint [6] 0 0
baseline and 14 weeks
Secondary outcome [7] 0 0
Change in interleukins
Timepoint [7] 0 0
baseline and 14 weeks
Secondary outcome [8] 0 0
Change in tumour necrosis factor a
Timepoint [8] 0 0
baseline and 14 weeks
Secondary outcome [9] 0 0
Change in macrophage migration inhibitory factor
Timepoint [9] 0 0
baseline and 14 weeks
Secondary outcome [10] 0 0
Change in plasma C- reactive protein
Timepoint [10] 0 0
baseline and 14 weeks
Secondary outcome [11] 0 0
Change in plasma and urinary advanced glycation end products
Timepoint [11] 0 0
baseline and 14 weeks
Secondary outcome [12] 0 0
Change in plasma and urinary advanced lipoxidation end products
Timepoint [12] 0 0
baseline and 14 weeks
Secondary outcome [13] 0 0
Change in general cognitive function
Timepoint [13] 0 0
baseline and 14 weeks

Eligibility
Key inclusion criteria
* Age >=18 or <=70 years
* Weight change < 5 kg in last 6 months
* HbA1c level <= 8%
* Patients with prediabetes (Impaired glucose tolerance and impaired fasting glycaemia) or type 2 diabetes (diet controlled or on oral therapy)
* Patients will have to be on oral therapy for diabetes (without changes in treatment) at least for 3 months.
* Patients will be advised not to change their pre-existing therapy for diabetes and cardiovascular risk factors for the duration of the study if HbA1c is not above 8%
* No recent blood transfusion (3 months)
* No current intake of anti-inflammatory medications and supplements
* No significant kidney, cardiovascular, haematological, respiratory, gastrointestinal, or central nervous system disease, as well as no psychiatric disorders, no active cancer within the last five years; no presence of acute inflammation (by history, physical or laboratory examination)
* Pregnant or lactating
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Age <18 or > 70 years
* HbA1c level of >= 8%
* Weight change > 5 kg in last 6 months
* Morbid obesity (body mass index >40 kg/m2)
* Current smoking habit and high alcohol use
* Patients on insulin
* Taking anti-inflammatory medications or supplements
* Recent blood transfusion history
* Kidney (estimated glomerular filtration rate < 30 ml/min), cardiovascular, haematological, respiratory, gastrointestinal, or central nervous system disease, as well as psychiatric disorder, active cancer within the last five years; presence of acute inflammation (by history, physical or laboratory examination)
* Pregnancy or lactation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Centre for Health Research and Implementation - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barbora de courten, MD,PHD,MPH
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Barbora de Courten, MD,PHD,MPH
Address 0 0
Country 0 0
Phone 0 0
+61 385722651
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02917928