Trial · NCT02917928
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Oral Glucose Tolerance Test | baseline and 14 weeks | 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. |
| Secondary | Change in HbA1c | baseline and 14 weeks | Blood samples will be measured using High Performance Liquid Chromatography. |
| Secondary | Change in lipid profile | baseline and 14 weeks | Blood samples will be analysed using High Performance Liquid Chromatography |
| Secondary | Change in systolic and diastolic blood pressure | baseline and 14 weeks | 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. |
| Secondary | Change in arterial stiffness and central blood pressure | baseline and 14 weeks | Aortic (carotid-femoral) pulse wave velocity (aPWV) will be measured using the non-invasive Complior device (Alam Medical, French). |
| Secondary | Change in markers of endothelial dysfunction | baseline and 14 weeks | 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). |
| Secondary | Change in heart rate variability | baseline and 14 weeks | 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. |
| Secondary | Change in interleukins | baseline and 14 weeks | Interleukins will be measured by quantitative sandwich enzyme immunoassays (R \& D Systems Inc, USA). |
| Secondary | Change in tumour necrosis factor α | baseline and 14 weeks | Tumour necrosis factor α (TNFα) will be measured by quantitative sandwich enzyme immunoassays (R \& D Systems Inc, USA). |
| Secondary | Change in macrophage migration inhibitory factor | baseline and 14 weeks | Macrophage migration inhibitory factor will be measured by quantitative sandwich enzyme immunoassays (R \& D Systems Inc, USA). |
| Secondary | Change in plasma C- reactive protein | baseline and 14 weeks | Plasma C- reactive protein (hsCRP) will be measured using high sensitivity assay (BN-II nephelometer; Dade Behring Diagnostics, NSW). |
| Secondary | Change in plasma and urinary advanced glycation end products | baseline and 14 weeks | 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. |
| Secondary | Change in plasma and urinary advanced lipoxidation end products | baseline and 14 weeks | 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). |
| Secondary | Change in general cognitive function | baseline and 14 weeks | 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. |
| Other | Change in liver stiffness and fat | baseline and 14 weeks | A non-invasive transient elastography (Fibroscan, EchoSens, Paris) will be used to assess liver fibrosis based on the measurement of liver fat and stiffness |
| Other | Change in Serum and urine carnosine | baseline and 14 weeks | This will be measured by ELISA for human carnosinase 1 (CN1) with a monoclonal antibody (clone ATLAS, Abcam plc) and peroxidase substrate . |
| Other | Change in skeletal muscle fat and density | baseline and 14 weeks | We will also measure the change in muscle and fat tissue density of participants' non-dominant leg using Quantitative Computed Tomography (pQCT). Participants will be seated in their non-dominant leg positioned inside the machine gantry. Muscle cross sectional area (mm2) and muscle density (mg/cm3) will be determined using the manufacturer's algorithms. |
| Other | Change in body composition | baseline and 14 weeks | body composition by dual energy x-ray absorptiometry (DEXA), which is a non-invasive assessment of soft tissue composition by region with a precision of 4-5%; central adiposity assessed in duplicate using a constant-tension tape for taking waist, and hip circumference. Bioimpedance measurement will be also collected for validation purposes. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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