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

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.

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

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Diabetes Mellitus; Metabolic Syndrome; Pre-Diabetes
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Study dietary supplement (PreCrea 600 mg capsules)

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380015
      • Dia Care- Diabetes Care and Hormone Clinic
  • Karnataka
    • Bangalore, Karnataka, India, 560034
      • St. Johns College and Hospital
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452010
      • Totall Diabetes and Hormone Institution
  • Maharashtra
    • Mumbai, Maharashtra, India, 411007
      • Bhatia Hospital
    • Pune, Maharashtra, India, 411040
      • Inamdar Multispeciality Hospital
  • Rajasthan
    • Jaipur, Rajasthan, India, 302018
      • Diabetes Care Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PreCrea; 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.	Dietary supplement: 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.; Other Names: PreCrea, Natural Sugar Lowerig Supplement, Predisease
Placebo Comparator: Placebo 600 mg capsules; Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.	Dietary supplement: Placebo; Other Names: Placebo 600mg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Hemoglobin A1c (Hb A1c) levels	Change in HbA1c % from baseline (Day 1) to end of supplementation/treatment after 90 days	Day 1(Baseline) to Day 90 (End of Study)
Safety of Dietary Supplement PreCrea 600 mg twice-daily	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)	Day 1 (Baseline) to Day 90 (End of Study)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Dietary Supplement PreCrea 600 mg twice-daily with Liver Function	Measure changes in Liver Function Tests: Aspartate Aminotransferase (AST) from baseline (Day 1) to End of Study (Day 90); Alanine Aminotransferase (ALT) from baseline (Day1) to End of Study (Day 90); Alkanine Phosphatase (ALP) from baseline (Day1) to End of Study (Day 90	Baseline (Day 1) to End of Study (Day 90)

Collaborators and Investigators

• Sponsor: Joe Fenn

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 14, 2014

Study Record Updates

• Last Update Posted (Estimate): May 18, 2015
• Last Update Submitted That Met QC Criteria: May 14, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: hyperglycemia; Pre-Diabetes; High blood sugar; High HbA1C; Natural Supplement for Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Hyperglycemia; Diabetes Mellitus; Metabolic Syndrome; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: Precre/Nutra001/PMI13