Study to Evaluate Safety and Efficacy of PreCrea® on Subjects With Higher Than Normal Blood Sugar Levels

Phase 3

Completed

• Conditions: Hyperglycemia; Diabetes Mellitus; Metabolic Syndrome; Pre-Diabetes
• Interventions: Dietary Supplement: Study dietary supplement (PreCrea 600 mg capsules); Dietary Supplement: Placebo

• Registration Number: NCT02189005
• Lead Sponsor: Joe Fenn

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of PreCrea® on subjects with higher than normal blood sugar levels.

Detailed Description

A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the efficacy and safety of PreCrea®, a twice-daily dietary supplement in people with higher than normal blood sugar levels.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-14
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-14
• Last Update Posted: 2015-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Age ≥ 18 years to ≤ 65 years
2. Newly diagnosed Male or Female participants with higher than normal blood sugar levels (FPG >100 mg/dL) on of Pre-Diabetes and Diabetes Mellitus during screening and not on any treatment
3. Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures

Exclusion Criteria

1. Subjects with Type 1 Diabetes Mellitus
2. Participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes.
3. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
4. Cardiac status New York Heart Association class III-IV
5. Uncontrolled blood pressure > 150 mmhg systolic and > 100 mmhg diastolic
6. Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female
7. Clinically significant peripheral edema
8. Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
9. Participants on steroid
10. Pregnancy or lactating women
11. Known hypersensitivity to any of the study drugs
12. Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.
13. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
14. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
15. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study.
16. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PreCrea	Study dietary supplement (PreCrea 600 mg capsules)	Study dietary supplement (Precrea 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with life style modification program.
Placebo 600 mg capsules	Placebo	Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.

Primary Outcome Measures

Name	Time	Method
Safety of Dietary Supplement PreCrea 600 mg twice-daily	Day 1 (Baseline) to Day 90 (End of Study)	Measure changes in Renal Function Tests: Blood Urea Nitrogen (BUN) from baseline (Day 1) to end of study (Day 90); Serum Creatinine from baseline (Day 1) to end of study (Day 90)
Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Hemoglobin A1c (Hb A1c) levels	Day 1(Baseline) to Day 90 (End of Study)	Change in HbA1c % from baseline (Day 1) to end of supplementation/treatment after 90 days

Secondary Outcome Measures

Name	Time	Method
Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Fasting Plasma Glucose (FPG)	Day 1 (Baseline) to Day 90 (End of Study)	Change in FPG % from baseline (Day1) to end of supplementation/treatment after 90 days

Trial Locations

Locations (6)

Diabetes Care Centre; 🇮🇳 Jaipur, Rajasthan, India

St. Johns College and Hospital; 🇮🇳 Bangalore, Karnataka, India

Totall Diabetes and Hormone Institution; 🇮🇳 Indore, Madhya Pradesh, India

Bhatia Hospital; 🇮🇳 Mumbai, Maharashtra, India

Dia Care- Diabetes Care and Hormone Clinic; 🇮🇳 Ahmedabad, Gujarat, India

Inamdar Multispeciality Hospital; 🇮🇳 Pune, Maharashtra, India