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Impact on Glycemic Variability After Treatment With Dapagliflozin on Type 2 Diabetes Patients

2019-09-20 03:46:47 | BioPortfolio

Summary

Glycemic variability is refered as swings in glucemic concentration throughout the day, including preprandial and postprandial glucose, and it has been proposed that could be determinant in the development in microvascular complications of type 2 diabetes (Brownlee and Hirsch 2006) SGLT2 inhibitors (SGLT2i) are a novel group of medications for treating type 2 diabetes patients but their effect on glucose variability, and oxidative stress has not been determined as a primary endpoint in clinical trials of type 2 diabetes mellitus patients. The aim of this study is to compare the effect of SGLT2 inhibition on glucose variability, oxidative stress and inflammatory disease biomarkers (VCAM-1) on new onset type 2 DM patients.

Description

The aim of this study is to compare the effect of SGLT2 inhibition on glucose variability, oxidative stress and inflammatory disease biomarkers (VCAM-1) on new onset type 2 DM patients. Methods: The investigators will include 36 patients with type 2 diabetes diagnosis with an Hba1c ≥ 7.5% and ≤ 9%, with BMI > 25 and <45 kg/m2, drug-naïve subjects. Subjects enrolled will be randomized 1:1 to either receive a daily dosage of dapagliflozin 10 mg and 2000 mg metformin for 12 weeks (n=18) or 2000 mg metformin (n=18). Patients who do not tolerate metformin at 2000mg dose will be downtitrated to 1500 mg daily. In case patients do not tolerate 1500 mg daily, they will be excluded. Patients who do not achieve glycaemic control, another antihyperglycaemic drug can be used.

Both groups will be monitored for 7 days using either iPro™ CGM system (Medtronic, Northridge, CA) or Dexcom G6 CGM (Dexcom Inc, San Diego, CA), or other available in Mexico. Basal continuous glucose monitoring will start at week 1 (first visit), and removed at day 7 and final continuous glucose monitoring will start at week 11 and removed 7 days after (final visit).

The main variables of interest are going to be in order of importance the delta of change (before and after study entry) of: 1.- glycaemic variability, 2.- change in Hba1c. 3.- change in oxidative stress status, 4. change in VCAM-1, 5.- change in weight, 6.- Blood pressure and 7.- waist circumference; before and after SGLT2i. The expected results are: compared to standard treatment, dapagliflozin arm will have lower glycaemic variability, higher reduction in Hba1c, lower oxidative stress, lower inflammsatory biomarker levels, and lower blood pressure

Study Design

Conditions

Type 2 Diabetes

Intervention

Continuous glucose monitoring

Location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ''
Ciudad de mexico
Mexico
14080

Status

Recruiting

Source

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-20T03:46:47-0400

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Medical and Biotech [MESH] Definitions

A glucoside-derived SODIUM-GLUCOSE TRANSPORTER 2 inhibitor that stimulates urinary excretion of glucose by suppressing renal glucose reabsorption. It is used to manage BLOOD GLUCOSE levels in patients with TYPE 2 DIABETES.

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

Self evaluation of whole blood glucose levels outside the clinical laboratory. A digital or battery-operated reflectance meter may be used. It has wide application in controlling unstable insulin-dependent diabetes.

A 51-amino acid pancreatic hormone that plays a major role in the regulation of glucose metabolism, directly by suppressing endogenous glucose production (GLYCOGENOLYSIS; GLUCONEOGENESIS) and indirectly by suppressing GLUCAGON secretion and LIPOLYSIS. Native insulin is a globular protein comprised of a zinc-coordinated hexamer. Each insulin monomer containing two chains, A (21 residues) and B (30 residues), linked by two disulfide bonds. Insulin is used as a drug to control insulin-dependent diabetes mellitus (DIABETES MELLITUS, TYPE 1).

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

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