To check how GlucoSEB affects the blood sugar level of diabetic and prediabetic patients after eating a meal.

Phase 2

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2023/10/058380
• Lead Sponsor: Advanced Enzymes Technologies Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Subjects will be included in the study if they meet all of the following criteria:

1. Age =30 years, and of any gender.

2. Subjects with limited physical activity

3. BMI: 25 to 40 Kg/m2

4. Subjects who consume diet rich in carbohydrates ( >60%)

5. Subjects taking stable medicine dose for past 3 months

6. For prediabetic group, subjects with fasting blood sugar level (100-125 mg/dL) and HbA1c: 5.7 to 6.4%

7. For diabetic group, subjects with fasting blood sugar level (= 130 mg/dL) and HbA1c: 7.0 to 9.5%

8. For diabetic group, subjects who are consuming biguanides (Metformin), sulfonylurea, SGLT-2 inhibitors, thiazolidinediones for blood glucose control.

9. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.

Exclusion Criteria

Subjects will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:

1. Pregnant and lactating female.

2. Subjects with BMI = 40

3. Type I diabetic patients

4. For prediabetic group, subjects who are taking any sugar control supplements.

5. For diabetic group, subjects who are under the DPP-4 inhibitor, incretin mimetic, glucosidase inhibitor, rapid acting/short acting/ intermediate acting and premixed insulin-based treatment.

6. Subject with major chronic complications (including but not limited to) autoimmune disease, inflammation, etc.

7. Organic insufficiency (cardiac, hepatic, renal, respiratory)

8. Use of food supplements specifically containing fibers or polysaccharides

9. Chronic smoking and alcohol intake

10. Allergy to the ingredients in the test product.

11. History of any surgery in the past 3 months.

12. Subject currently taking or has in the past 30 days used GI related probiotics/prebiotics or any enzymes [prescription or over the counter (OTC)].

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postprandial glucose monitoring: <br/ ><br>Incremental increase in glucose concentration (iAUC) after standard meal consumption, comparison in response among placebo and test <br/ ><br>Timepoint: Postprandial glucose monitoring: <br/ ><br>Visit 3, 4, 5 and 6

Secondary Outcome Measures

Name	Time	Method
1. Maximum glucose concentration, Cmax: <br/ ><br>Determining maximum glucose concentration obtained after consumption of standard meal. <br/ ><br> <br/ ><br>2. Time required to reach maximum glucose, Tmax: <br/ ><br>Determining time required to reach maximum glucose concentration after consumption of standard meal <br/ ><br> <br/ ><br>3. Insulin secretion: <br/ ><br>Determining difference in insulin response after consuming standard meal among two arms, control & test. <br/ ><br>Timepoint: 1. Maximum glucose concentration, Cmax: Visit 3, 4, 5 & 6 <br/ ><br> <br/ ><br>2. Time required to reach maximum glucose, Tmax: Visit 3, 4, 5 & 6 <br/ ><br> <br/ ><br>3. Insulin secretion: Visit 3 & 5 at 0 hour, 2 hour & 4 hour