A STUDY TO EVALUATE THE EFFECT OF EDIBLE OIL IN PATIENTS OF TYPE II DIABETES MELLITUS & HYPERTENSION.

Phase 3

• Registration Number: CTRI/2010/091/000389
• Lead Sponsor: Adani Wilmar Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Male or Female > or = 18 yrs of age.
DM diagnosed at least 3 months prior to screening.
HT diagnosed at least 1 month prior to screening
The subject should have HbA1c > or = 7.0 % and < or = 11.5 % on screening
The subject should have msDBP > or = 85 mm Hg and <110 mm Hg on screening.
The subject should be on a stable dose of OHAs and anti hypertensive for 1 month prior to screening.
If patient is on lipid lowering agents, therapy should be stable for 1 month prior to screening
Body Mass Index > or = 20 kg/m2 and < or = 45 kg/m2.
Subject should be capable of understanding and complying with protocol
requirements.
Subject or the subject`s legally acceptable representative signs a written, informed consent form prior to initiation of any study procedure.
No major illness or debility that in the investigator`s opinion prohibits the subject from completing the study.

Exclusion Criteria

History / Evidence of allergy or hypersensitivity to any edible oils used for preparing food.
Subjects receiving Insulin for treatment of DM.
History of a psychiatric disorder that will affect the subject`s ability to participate in the study.
History of alcohol or substance abuse within the 2 years prior to screening.
History of treatment with any weight loss drugs or oral or systemically injected steroids within 3 months prior to screening.
Receipt of any investigational drug within the 30 days prior to screening.
Prior treatment in an investigational study of any edible oil used for preparing food.
Subject is a study site employee, or is an immediate family member of a study site employee who is involved in the conduct of this study.
Systolic blood pressure > 180 mm Hg and / or diastolic pressure >110 mm Hg.
Lab values for exclusion:
Serum Triglycerides >500 mg/dl LDL Cholesterol- >200 mg/dl FBS- <110 mg/dl and >240 mg/dl
History of any haemoglobinopathy that may affect determination of HbA1c.
Patient has had any of the following within the past 12 months.
a) Acute coronary syndrome (e.g. : MI or unstable angina)
b) Coronary artery intervention (CABG or PTCA)
c) Stroke or transient ischemic neurological disorder.
Patient has congestive cardiac failure or a history of congestive heart failure.
Subject with any significant ECG abnormalities
Subject with any life threatening illness or any history of cancer or malignancy.
History of any serological abnormality or infection with HIV.
Subject on use of antioxidants or omega 3 supplements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of RBS8020 on HbA1c, Lipid profile & Blood pressure change from baseline to week 12 in patient with Type 2 Diabetes Mellitus & HypertensionTimepoint: 12 Weeks

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI