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Type II Diabetes Mellitus Reversal Study

Not Applicable
Conditions
Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Registration Number
CTRI/2020/02/023258
Lead Sponsor
Bangalore Diabetes Centre and Diagnostic Lab
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1) Own smartphone and capable of using for TPNP

2) Diabetic : Not on DM Rx with HbA1c > 6.4 or on DM Rx with any HBA1c

3) Adequate Hepatic Function : AST/ALT less than or equal 3.0 x ULN

4) Adequate Renal Function define by

a. Serum Cretinine less than or equal 1.5 mg/dl

b. and/or eGFR > 60 mL/min/1.73 me

5) BMI greater than or equal 18.5 Kg/m2

Exclusion Criteria

1) Type 1 Diabetes, LADA, MODY, Fibrocalculous pancreatic diabetes (FCPD), Gestational Diabetes Mellitus (GDM)

2) History of keto-acidosis

3) History of myocardial infraction stroke, angina or coronary insufficiency within the last 3 month

4) Need for current chronic corticosteroid therapy (greater than or equal 2.5mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)

5) Major psychiatric disorder (eg schizophrenia, bipolar disorder)

6) Major surgical procedure or significant traumatic injury within 28 days prior to enrollment date

7) Patients who have undergone any bariatric procedures

8) Pregnant and lactating females

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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