A Study to Assess Effect of Glucocil® on Metabolic Health in Individuals With Prediabetes and Type 2 Diabetes Mellitus.

Korábbi kezelés

• Individuals who are currently on diuretics or thyroid supplements
• Individuals on lipid-lowering therapies.
• Individuals who are currently on antihypertensive medication.
• Individuals taking concomitant medication known to alter blood sugar.
• Individuals having treatment with herbal or any other supplements.
• Use of another investigational product within 3 months of the screening visit.

Más betegség

• Individuals with Type 1 diabetes mellitus.
• Individuals with Type 2 diabetes mellitus on medication.
• Individuals with any other endocrine disorder.
• Individuals with cardiac arrhythmia, impaired hepatic or renal function
• Individuals having heart failure, coronary artery disease, hyperthyroidism, hypothyroidism, cancer or mental disease or any other serious disease requiring active treatment.
• History of malignancy or stroke.
• Any condition or abnormality that would compromise the safety of the individuals or the quality of the study data.

Egyéb

• Individuals who are exclusively vegetarians diet.
• Individuals with uncontrolled hypertenstion as assessed by systolic over diastolic blood pressure (≥ 140/90 mmHg).
• Chronic alcoholism: History and/or current cases of chronic alcohol consumption or heavy drinkers as defined by i.For men consuming more than 4 drinks on any day or more than 14 drinks/week ii. For women, consuming more than 3 drinks on any day or more than 7 drinks/week
• Females who are lactating, pregnant or planning to be pregnant or taking any oral contraceptives

• Males and females of age more than equal to 30 years and less than equal to 70 years.
• Body mass index within 30 kg/m2 and 35 kg/m2 (both values included) with waist circumference above 40 inches (men) or 35 inches (women).
• Cohort 1 (Only for prediabetes individuals)- Individuals diagnosed with prediabetes with OGTT (140 mg/dL to 199 mg/dL); HbA1c (5.7% to 6.9%) and fasting blood glucose level (between 100 mg/dL to 125 mg/dL).
• Cohort 2 (T2DM)- Individuals newly diagnosed with Type 2 diabetes mellitus with HbA1c between 7% and 9% (both values included) and fasting blood glucose level in between 126 to 180 mg/dL.
• Triglycerides between 150 mg/dL and 299 mg/dL (both values inclusive) and/or Low-Density Lipoprotein (LDL) in between 130 mg/dL and 189 mg/dL (both values inclusive).
• Individuals having non-vegetarian diet for at least 2 days a week.
• Non-smoker.
• Individuals who are willing to not change their physical activity levels throughout the study period.
• Individuals willing to complete all study-related questionnaires and to complete all clinical study visits.
• Individuals ready to give voluntary, written informed consent to participate in the study.