REFERENCE ID : 2018-03800

 

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Effect of Sodium
Glucose Co-transporter-2 (SGLT-2) Inhibitors on blood pressure in diabetic
patients in Outdoor Patient Department in a Tertiary Care Hospital.

 

INTRODUCTION :

Sodium-glucose
co-transporter-2 (SGLT-2) inhibitors are newly
acclaimed class hypoglycemic medications with a unique mechanism of action for
treating Type 2 Diabetes mellitus. The drugs act on the kidneys to
lower blood glucose
levels. These agents cause an increase in glycosuria,
leading to improved glucose regulation. SGLT-2 inhibitors have been
approved for use as a treatment for
diabetes since 2013.

 

SGLT2
inhibitors work by impeding the kidneys from
reabsorbing glucose back into the blood. This enables the kidneys to decrease
blood glucose levels and the surplus glucose in the blood is removed from the
body via urine. These drugs inhibit the Cotransporter molecules, which function
to reabsorb glucose into the blood. SGLT-2 inhibitors may be suitable for
people with type 2 diabetes that have increased blood glucose levels despite
being on hypoglycemic medication  like metformin and
insulin. By removing glucose from the body, SGLT-2 inhibitors also aid in 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 SGLT-2 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.

 

 

REFERENCES
:

1.     
https://www.diabetes.co.uk/diabetes-medication/sglt2-inhibitors.html

Diabetes Care Volume 38, March 2015 pg
429-430 ©American Diabetes Association

Blood Pressure Reduction: An added benefit of Sodium
Glucose Cotransporter 2 Inhibitors in Patients with Type 2 Diabetes Mellitus

-Colleen Majewski And George L. Bakris

2.     
 Canagliflozin:
a review of its use in patients with type 2 diabetes
mellitus. Drugs 2014;74:807–824pmid:24831734

3.     
Dapagliflozin:
a review of its use in patients with type 2 diabetes.Drugs 2014;74:2191–2209pmid:25389049

4.       Blood pressure effects of sodium-glucose co-transport
2 (SGLT2) inhibitors. J Am Soc Hypertens 2014;8:330–339pmid:24631482

 

 

 

 

 

 

 

 

 

 

 

 

Annexure
1

Informed
Consent Form

 

 

 I,                                                                         ,
the undersigned have been explained about the research project – “Effect of
Sodium Glucose Co-transporter-2 (SGLT-2) Inhibitors on blood pressure in diabetic
patients in Outdoor Patient Department in a Tertiary Care Hospital”. I
understand that this study includes collection of data and measurement of blood
pressure. I understand that this study will not have any harmful effect on my
body. I hereby give my consent to be included in this study.

 

 

 

 

Signature
of Participant                                                                               Signature
of Researcher

Date :                                                       
                                                   Date :

 

 

 

Signature of Witness

Date :

 

 

 

Annexure
2

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         Annexure 4Case Record Form

Patient’s Name:

 

Patient ID :

 

Age:

 

Sex:

 

Duration of Type 2 Diabetes Mellitus:

 

Concomitant medications:

 

 
Sr.
No.
 

 
Brand
Name

 
Generic
Name

 
Dose

 
Dose
freq.

 
Route

 
Formula-tion

 
Time
of
Administ-ration
 

 
Type

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
Hypoglycemics
(H)
 
Antihypertensives
(A)
 
Statins
(ST)
 
Diuretics
(D)
 
Steroids
(S)
 
Any
other (Specify)
 
 

Other Complications:
 

Retinopathy
 
Neuropathy
 
Nephropathy
 
Hyperosmolar
Coma
 
Diabetic
Ketoacidosis
 
Diabetic
Foot Ulcers
 
Peripheral
Vascular Disease
 
Stroke
 
Coronary
Artery Disease
 
Any
Other (Specify)
 
 

Glycemic Control:

Date of
tests-______________
FBS
PPBS
RBS
 
HbA1c
 

SGLT-2 Therapy:

Dapagliflozin
 
Canagliflozin
 
Empagliflozin
 

Duration  of
SGLT-2 Therapy:

 

Other Tests (optional):

 
 
 
 
 

Co- morbidity:

Hypertension:

 
Any
Other (Specify)
 
 

Blood Pressure:
(Day 0)

Supine
 
Sitting
 

 

 

Annexure
5

GANTT
CHART

Activity/
Observation

DAY 0

FUP1(Day 15)
(Optional)

FUP2(Day 30-45)

 
Informed Consent
 

 

 

 

 
Inclusion /Exclusion
Criteria
 

 

 

 

 
Enrollment
 

 

 

 

 
Clinical CRF
 

 

 

 

 
Supine blood Pressure
 

 

 

 

 
Sitting blood
Pressure
 

 

 

 

 
RBS