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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02917928
Registration number
NCT02917928
Ethics application status
Date submitted
19/09/2016
Date registered
28/09/2016
Date last updated
28/06/2022
Titles & IDs
Public title
The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health
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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
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Secondary ID [1]
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16061AI
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Poor Glycemic Control
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Cardiovascular Risk Factors
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Cognitive Function 1, Social
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - 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
Other interventions: 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
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Oral Glucose Tolerance Test
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Assessment method [1]
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After a 10-12 h overnight fast, participants will ingest 75g of glucose over 2 mins. Blood samples will be drawn at 0, 30, 60, 90 and 120 min for plasma glucose and insulin concentrations. We will evaluate the area under the curve.
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Timepoint [1]
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baseline and 14 weeks
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Secondary outcome [1]
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Change in HbA1c
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Assessment method [1]
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Blood samples will be measured using High Performance Liquid Chromatography.
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Timepoint [1]
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baseline and 14 weeks
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Secondary outcome [2]
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Change in lipid profile
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Assessment method [2]
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Blood samples will be analysed using High Performance Liquid Chromatography
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Timepoint [2]
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baseline and 14 weeks
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Secondary outcome [3]
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Change in systolic and diastolic blood pressure
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Assessment method [3]
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Resting systolic and diastolic blood pressure and pulse rate will be measured using an automated oscillometric measurement system (Dinamap, USA) after a 30 minute rest.
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Timepoint [3]
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baseline and 14 weeks
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Secondary outcome [4]
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Change in arterial stiffness and central blood pressure
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Assessment method [4]
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Aortic (carotid-femoral) pulse wave velocity (aPWV) will be measured using the non-invasive Complior device (Alam Medical, French).
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Timepoint [4]
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baseline and 14 weeks
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Secondary outcome [5]
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Change in markers of endothelial dysfunction
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Assessment method [5]
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This is done using non-invasive peripheral arterial tomography (PAT; endothelium-dependent digital pulse amplitude testing (EndoPAT), Itamar Medical Ltd, Israel), which records continuous plethysmographic signals of the finger arterial pulse wave. Finger plethysmographic probes are placed on each index finger; and after a 5 min equilibration period, a blood pressure cuff on the non-dominant arm is inflated to 60 mmHg above systolic for 5 min and then deflated to induce reactive hyperaemia. Measurements of post-occlusion changes (reactive hyperaemia PAT: RH-PAT) are continued for 10 min. Results are normalised to the non-occluded arm, compensating for potential systemic changes (RH-PAT ratio).
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Timepoint [5]
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baseline and 14 weeks
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Secondary outcome [6]
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Change in heart rate variability
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Assessment method [6]
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The Zephyr Biomodule BH3 (Black Sensor, produced by Zephyr Technology) will be used to measure heart rate and heart rate variability for three consecutive days.
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Timepoint [6]
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baseline and 14 weeks
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Secondary outcome [7]
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Change in interleukins
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Assessment method [7]
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Interleukins will be measured by quantitative sandwich enzyme immunoassays (R & D Systems Inc, USA).
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Timepoint [7]
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baseline and 14 weeks
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Secondary outcome [8]
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Change in tumour necrosis factor a
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Assessment method [8]
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Tumour necrosis factor a (TNFa) will be measured by quantitative sandwich enzyme immunoassays (R & D Systems Inc, USA).
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Timepoint [8]
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baseline and 14 weeks
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Secondary outcome [9]
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Change in macrophage migration inhibitory factor
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Assessment method [9]
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Macrophage migration inhibitory factor will be measured by quantitative sandwich enzyme immunoassays (R & D Systems Inc, USA).
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Timepoint [9]
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baseline and 14 weeks
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Secondary outcome [10]
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Change in plasma C- reactive protein
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Assessment method [10]
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Plasma C- reactive protein (hsCRP) will be measured using high sensitivity assay (BN-II nephelometer; Dade Behring Diagnostics, NSW).
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Timepoint [10]
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baseline and 14 weeks
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Secondary outcome [11]
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Change in plasma and urinary advanced glycation end products
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Assessment method [11]
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Measured by liquid chromatography-tandem mass spectrometry and ELISA tests. Circulating receptor for AGEs will be measured by ELISA. Protein modifications and the effect of carnosine supplementation will be determined by proteomic approaches.
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Timepoint [11]
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baseline and 14 weeks
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Secondary outcome [12]
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Change in plasma and urinary advanced lipoxidation end products
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Assessment method [12]
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This will be determined by measuring the advanced oxidation protein products and by measuring the cysteinate form of albumin by mass spectrometry. Mercapturic acid adducts with the main reactive carbonyls species will also be quantitatively determined by liquid chromatography electrospray ionization mass spectrometry/mass spectrometry analysis (LC-MS/MS).
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Timepoint [12]
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baseline and 14 weeks
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Secondary outcome [13]
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Change in general cognitive function
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Assessment method [13]
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Participants' cognitive function will be assessed using Cambridge Neuropsychological Test Automated Battery (CANTAB) battery for Prodromal Alzheimer's disease, Victoria Stroop test, Trail Making Test and Digit Symbol Substitution Test.
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Timepoint [13]
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baseline and 14 weeks
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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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2023
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Centre for Health Research and Implementation - Melbourne
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Recruitment postcode(s) [1]
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3168 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The investigators hypothesise that carnosine supplementation will improve:
1. glycaemic control
2. cardiovascular risk factors
3. cognitive outcomes
in patients with prediabetes and type 2 diabetes, and this will be modulated by reduction in
chronic low grade inflammation, oxidative stress and circulating advanced glycation end
products levels.
3. Aims
To determine the potential of carnosine supplementation for 14 weeks to improve glycaemic
control in type 2 diabetes, reduce risk factors for cardiovascular disease and improve
cognitive function as well as identify metabolic pathways involved, specifically by:
1. Improving glycaemic control (HBA1c, fasting and 2 hour glucose and glucose area under
the curve after oral glucose tolerance test)
2. Reducing cardiovascular risk factors (lipids; arterial (aortic) stiffness; central blood
pressure (cBP); endothelial function).
3. Improve cognitive function (global cognitive score formed by a composite of 4 cognitive
tests)
4. Decrease the chronic low grade inflammation, oxidative stress, advanced glycation end
products, and advanced lipoxidation end products, and increase detoxification of
reactive carbonyl species (RCSs).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02917928
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Barbora de courten, MD,PHD,MPH
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Barbora de Courten, MD,PHD,MPH
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Address
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Country
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Phone
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+61 385722651
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02917928
Download to PDF