Sodium-glucose
co-transporter-2 (SGLT2) inhibitors are a newly
approved class of glucose-lowering medications with a novel mechanism of action
for treating Type 2 Diabetes mellitus. The drugs work by helping the
kidneys to lower blood glucose
levels. These agents increase glycosuria,
which leads to improved glucose control. SGLT2 inhibitors have been
approved for use as a treatment for
diabetes since 2013.

 

SGLT2
inhibitors work by preventing the kidneys from
reabsorbing glucose back into the blood. This allows the kidneys to lower blood
glucose levels and the excess glucose in the blood is removed from the body via
urine. These drugs inhibit a form of proteins, which help to reabsorb glucose
into the blood, called sodium-glucose transport proteins (SGLT2). By blocking
these

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SGLT2
inhibitors may be suitable for people with type 2 diabetes that have high blood
glucose levels despite being on a medication regimen such as metformin and
insulin. By removing glucose from the body, SGLT2 inhibitors can also have
benefits for weight loss.1 They also produce an osmotic diuresis that, in part,
contributes to blood pressure reduction secondary to glycosuria.2,3 . Dapagliflozin,
Canagliflozin,  Empagliflozin are the
three SGLT-2 Inhibitors.

 

A recent review of SGLT2 inhibitors focuses
on the blood pressure–lowering effects of the two approved glucose-lowering
agents, dapagliflozin and canagliflozin.4 While
not approved as antihypertensive agents, they may potentially aid in lowering
blood pressure in patients with diabetes. A review of studies in both
hypertensive and normotensive patients with type 2 diabetes demonstrates a 4–10
mmHg reduction of systolic blood pressure.4

Diabetes
and hypertension frequently occur together. There is substantial overlap
between diabetes and hypertension in etiology and disease mechanisms.

Hence
a common medication which can cause improvement in both conditions will improve
patient adherence and compliance.

Thus this research focuses on the antihypertensive
effects of SGLT-2 Inhibitors in addition to its hypoglycemic effects.

 

OBJECTIVES :

·        
To study the lowering
of blood pressure with the use of SGLT-2 Inhibitors in Type 2 Diabetes Mellitus
patients in Outdoor Patient Department.

 

METHODOLOGY :

The study will begin after obtaining permission from the Indian
Council of Medical Research & the Institutional Ethics Committee. The approval
of the HOD & hospital superintendent will be taken & written consent of
the patient that will be obtained in their vernacular language (Annexure 1,2,3).
Consenting patients will be informed that their participation is entirely
voluntary and that they can drop out of the study at any given point of time.
Moreover, the confidentiality of the data will be maintained. Selection
criteria will be applied:

 

Selection
Criteria

 

 

 

 

 

         Inclusion Criteria                                                                            Exclusion Criteria

1.     
Age
greater than 18 years                                                            1. Age less than 18 years                                                                                 

2.      Patients attending the                                                                   2.
Presence of Diabetic

Endocrine OPD in the                                                                        Ketoacidosis

Hospital with Type 2 Diabetes                                                     3. Patient taking

Mellitus                                                                                           
antihypertensive

3.      Patients willing to give                                                                    medication                  

informed consent to                                                                         

participate in the study                    

4.      Patients undergoing SGLT-2               

therapy in addition to other

hypoglycemic medications.

5.      Both male and female patients

will be enrolled

 

Study Design:

This will be a prospective follow-up observational
study of 8 weeks duration and will be carried out on the patients visiting the
Endocrine OPD at a tertiary care hospital who are diagnosed with Diabetes for at
least six months. The consenting patients will be entered into the study.
First, a Case Record Form (Annexure 4) will be filled by the researcher from the
OPD book and the Case paper.

Subsequently their blood pressure will be measured
following the standard guidelines and would be entered both in the Case Record
Form (Annexure 4) and Gantt chart (Annexure 5) in the    Day 0 field. The blood pressure will be
measured both in sitting and supine position. The blood pressure will be
measured again during the follow-up visit after 30-45 days both sitting and
supine and recorded in the Gantt chart (Annexure 5). An optional blood pressure
measurement can be carried out on Day 15 when the patient comes for a follow-up
visit.

 

Recommendations
for Blood pressure measurement:

·        
The position of the patient can have a
sizable impact on blood pressure measurements. For the most accurate
measurement, the American Heart Association(AHA) recommends that the patient be
relaxed and seated with legs uncrossed and back and arm supported. If possible,
the patient should be seated five minutes before the reading. The arm should be
uncovered

·        
The AHA recommends that at least two
readings be taken, with a one-minute interval between them, and the average of
the measurements recorded. The first reading in a series is usually the highest.
Additional readings should be taken if the difference between the first two is
greater than 5 mm Hg.

·        
Patient’s arm should be supported at heart level.

·        
Mercury column should be deflated at 2 to3 mm per second.

·        
Neither the patient nor the person taking the measurement
should talk during the procedure.

 

Statistical Analysis:

Data will be entered
into the Microsoft Excel, 2016 version and will be analyzed for the
sustainability of efficacy and other different variables by using Paired t test
and ANOVA will be used for the comparison of the three drugs. p value less than
0.05 will be considered significant. All the statistical analysis will be done
by using SPSS (Statistical Package for Sciences) version 23.0 (IBM corporation
California).

 

 

 

IMPLICATIONS :

·        
Establishing the role of SGLT-2 Inhibitors as hypoglycemic
and antihypertensive agents

·        
The outcome of the research will be used to emphasize the
blood pressure lowering effect of SGLT-2 Inhibitors.

·        
A common drug will be used in patients suffering from type 2
diabetes mellitus with hypertension thereby improving patient adherence and
compliance to medication.