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Clinical Trial Details

Trial ID: L6228
Source ID: NCT02879409
Associated Drug: Metformin
Title: HbA1c Variability in Type II Diabetes
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: Metformin|DRUG: Gliclazide|DRUG: Sitagliptin|DRUG: Liraglutide|DRUG: Pioglitazone|DRUG: Dapagliflozin|DRUG: human insulin
Outcome Measures: Primary: Determination of the variability of HbA1c (by measurement of standard deviation of HbA1c) between the 2 diabetes treatment thresholds, The primary objective of this study is to determine whether treatment to one of 2 threshold levels will result in one group of type 2 diabetes patients having the same mean HbA1c but with differing HbA1c variability to that of another., 24-30 months | Secondary: Association of the variability of HbA1c (by measurement of standard deviation of HbA1c) to microvascular changes in heart rate variability, corneal nerve fiber density, albumin/creatinine ratio and estimated glomerular filtration rate., Heart rate variability will be measured by ECG changes to deep breathing. Corneal nerve fiber density will be measured by confocal corneal microscopy, 24-30 months|Association of the variability of HbA1c (by measurement of standard deviation of HbA1c) to oxidative stress markers measured by urinary isoprostanes and inflammation measured by highly sensitive C-reactive protein., This will be assessed by comparing the results of HbA1c and it's variability every 6 weeks with results of routine biochemistry including eGFR, lipids, SHBG, hsCRP measured on visit one (initial visit), visit 11 (midpoint of the study), and visit 20 (end of the study)., 24-30 months|Comparison of HbA1c (percent) for each subject at baseline and following sample storage of 2 years to assess HbA1c measurement stability., HbA1c will be measured at the time of the sample collection from fresh and haemolysed blood, then the remaining of the samples will be aliquoted and stored in -80 C then remeasured again after short term storage (2-3 years), 2-3 years.
Sponsor/Collaborators: Sponsor: Weill Cornell Medical College in Qatar | Collaborators: Hamad Medical Corporation|Sidra Medicine|University of Hull
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 150
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2016-11
Completion Date: 2024-10-01
Results First Posted:
Last Update Posted: 2023-12-14
Locations: Hamad Medical Corporation, Doha, 3050, Qatar
URL: https://clinicaltrials.gov/show/NCT02879409