Date of Defense
5-11-2024 1:00 PM
Location
CMHS Building
Document Type
Dissertation Defense
Degree Name
Doctor of Philosophy (PhD)
College
CMHS
Department
Pharmacology and Therapeutics
First Advisor
Prof. Salahdein Aburuz
Keywords
Diabetes, kidney, electrolyte, diet, exercise, metabolic, energy, carbohydrate, medication adherence, MTM, MPR, SDSCA, METs.
Abstract
The incidence of diabetes is increasing worldwide, consequently increasing mortality rates due to complications such as diabetic kidney disease. Clinical evidence on the protective effect of balanced diet, exercise and medication adherence with glucose-lowering intensification therapies on the progression of diabetes is insufficient, and interventions that are most effective in slowing cardiorenal metabolic complications in patients with type 2 diabetes mellitus (T2DM), especially in the UAE population diabetes remain to be elucidated. Several studies have shown that patient-related factors and limited medication adherence in patients with chronic diseases, are associated with poor clinical outcomes, long-term complications, and increased overall disease costs. Moreover, lifestyle modification involving active engagement of specialised dietitian with diet and exercise education, can be effective as first-line treatment for diabetes. The aim of this study was to determine the effect of long-term multi-factorial interventions, including medication therapy management with adherence reinforcement, structured diet as well as exercise adherence, and electrolyte levels optimisation on clinical outcomes in UAE patients with T2DM in ambulatory healthcare clinic. A randomised controlled clinical trial was conducted in an outpatient clinic, followed up 192 patients with diabetes allocated with blinded concealment to the intervention and control groups for 1 year. The intervention group received multi-factorial interventions, including serum electrolyte level optimisation, dietary and exercise counselling with a specialised dietician and a comprehensive pharmacist-led medication therapy management (MTM) involving private counselling and medication adherence assessment, while the control group received standard routine care in the clinic.
During a mean follow-up of 11.9 months, diabetes was controlled in 40.4 % of the intervention compared to 31.6 % in the control group, with significant mean difference of -0.63 (95% CI -0.96 – -0.30, P < 0.01). At the end of study period, participants in the multifactorial group reached significant mean difference in systolic blood pressure readings of = -4.21 )95% CI -8.26 – -0.16, P < 0.02), and LDL-c levels of = -0.31 )95% CI -063 – 0.02, P < 0.03), compared to control group. eGFR and serum albumin levels have been improved in the intervention group with non-significant difference. Moreover, the mean difference in the change in body mass index between study groups at study exit and baseline was statistically significant (BMI difference = -1.86, 95% CI -2.68 – -1.04, P < 0.01). The intervention group reported significant decrease in total carbohydrate and daily energy intake compared to baseline (173.7 g vs 221.1 g and 1828.5 kcal vs 2177.9 kcal, respectively). Moreover, the mean metabolic equivalents (METs) in the intervention group increased significantly at study exit from baseline compared to control group METs, with mean difference between all between-group differences after baseline of 0.63 (95% 0.29 – 0.97, P < 0.01). In addition, at 12 months follow-up, participants in the intervention group showed a statistically significant improvement in overall medication adherence with total (composite) medication possession ratio of mean (±SD) 0.95 (±0.09) compared to 0.92 (± 0.09) in the control group with mean difference of 0.03 (95%, CI 0.01-0.06), P =0.02. Implementing multifactorial interventions by a multidisciplinary team care improved several clinical manifestations including HbA1c, SBP, and eGFR with decreased cardiovascular risk factors. Furthermore, structured diet and exercise counselling was noted to be associated with significant weight and total calorie reduction and enhancement of physical activity compared to routine counselling in diabetes management. Besides, pharmacist-led MTM interventions was effective in persistently improving adherence to chronic medication and optimising medication regimens.
IMPACT OF MULTIFACTORIAL INTERVENTIONS WITH MEDICATION AND LIFESTYLE OPTIMIZATION ON PATIENTS WITH TYPE 2 DIABETES: A RANDOMISED CONTROLLED TRIAL
CMHS Building
The incidence of diabetes is increasing worldwide, consequently increasing mortality rates due to complications such as diabetic kidney disease. Clinical evidence on the protective effect of balanced diet, exercise and medication adherence with glucose-lowering intensification therapies on the progression of diabetes is insufficient, and interventions that are most effective in slowing cardiorenal metabolic complications in patients with type 2 diabetes mellitus (T2DM), especially in the UAE population diabetes remain to be elucidated. Several studies have shown that patient-related factors and limited medication adherence in patients with chronic diseases, are associated with poor clinical outcomes, long-term complications, and increased overall disease costs. Moreover, lifestyle modification involving active engagement of specialised dietitian with diet and exercise education, can be effective as first-line treatment for diabetes. The aim of this study was to determine the effect of long-term multi-factorial interventions, including medication therapy management with adherence reinforcement, structured diet as well as exercise adherence, and electrolyte levels optimisation on clinical outcomes in UAE patients with T2DM in ambulatory healthcare clinic. A randomised controlled clinical trial was conducted in an outpatient clinic, followed up 192 patients with diabetes allocated with blinded concealment to the intervention and control groups for 1 year. The intervention group received multi-factorial interventions, including serum electrolyte level optimisation, dietary and exercise counselling with a specialised dietician and a comprehensive pharmacist-led medication therapy management (MTM) involving private counselling and medication adherence assessment, while the control group received standard routine care in the clinic.
During a mean follow-up of 11.9 months, diabetes was controlled in 40.4 % of the intervention compared to 31.6 % in the control group, with significant mean difference of -0.63 (95% CI -0.96 – -0.30, P < 0.01). At the end of study period, participants in the multifactorial group reached significant mean difference in systolic blood pressure readings of = -4.21 )95% CI -8.26 – -0.16, P < 0.02), and LDL-c levels of = -0.31 )95% CI -063 – 0.02, P < 0.03), compared to control group. eGFR and serum albumin levels have been improved in the intervention group with non-significant difference. Moreover, the mean difference in the change in body mass index between study groups at study exit and baseline was statistically significant (BMI difference = -1.86, 95% CI -2.68 – -1.04, P < 0.01). The intervention group reported significant decrease in total carbohydrate and daily energy intake compared to baseline (173.7 g vs 221.1 g and 1828.5 kcal vs 2177.9 kcal, respectively). Moreover, the mean metabolic equivalents (METs) in the intervention group increased significantly at study exit from baseline compared to control group METs, with mean difference between all between-group differences after baseline of 0.63 (95% 0.29 – 0.97, P < 0.01). In addition, at 12 months follow-up, participants in the intervention group showed a statistically significant improvement in overall medication adherence with total (composite) medication possession ratio of mean (±SD) 0.95 (±0.09) compared to 0.92 (± 0.09) in the control group with mean difference of 0.03 (95%, CI 0.01-0.06), P =0.02. Implementing multifactorial interventions by a multidisciplinary team care improved several clinical manifestations including HbA1c, SBP, and eGFR with decreased cardiovascular risk factors. Furthermore, structured diet and exercise counselling was noted to be associated with significant weight and total calorie reduction and enhancement of physical activity compared to routine counselling in diabetes management. Besides, pharmacist-led MTM interventions was effective in persistently improving adherence to chronic medication and optimising medication regimens.