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Gycabiane and Glycemic Control of Prediabetic Subjects

This study is currently recruiting participants.
Verified February 2012 by Pileje
Sponsor:
Information provided by (Responsible Party):
Pileje
ClinicalTrials.gov Identifier:
NCT01530685
First received: December 5, 2011
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to examine the effects of supplementation Glycabiane, a dietary supplement, on glycemic control of overweight prediabetic subjects.


Condition Intervention Phase
Hyperglycemia
 Dietary Supplement: Glycabiane
Dietary Supplement: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pileje:

Primary Outcome Measures:
  • Fast Blood Glucose [ Time Frame: 4 months ]
    Fast blood glucose will be measured before and after 4 months of supplementation and after 2 months of wash-out


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glycabiane, gelule Dietary Supplement: Glycabiane
2 gelule per day for 4 months
Other Names:
  • Glycabiane
  • Dietary supplement
Placebo Comparator: Placebo Dietary Supplement: placebo
2 gelules per day for 4 months
Other Name: Placebo

Detailed Description:

Cinnamon's effects on blood glucose have been the subject of many clinical and animal studies; however, the issue of cinnamon intake's effect on fasting blood glucose (FBG) in people with prediabetes still remains unclear.

The main purpose of this study is to examine the effects of supplementation with Glycabiane, a dietary supplement rich in cinnamon extract, on fast blood glucose of overweight prediabetic subjects in a randomized, placebo-controlled, clinical trial.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female from 25 to 65 years old
  • 1.0g/L ≤ fast blood glucose < 1.26g/L
  • overweight (IMC > 25)

Exclusion Criteria:

  • thyroid disease
  • hypogonadism
  • History of musculoskeletal, autoimmune or neurological disease
  • Treatment against thyroid disease, hypoglycemia, hypertension, or anti-coagulant
  • Pregnant or lactating women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530685

Contacts
Contact: Karine Clément, Pr +33 1 42 17 79 19 karine.clement@psl.aphp.fr

Locations
France
CHU Pitié Salpetriere Recruiting
Paris, France, 75013
Contact: Salwa Rizkalla, Dr     +33 1 42 17 79 81     salwa.rizkalla@psl.aphp.fr    
Sponsors and Collaborators
Pileje
Investigators
Principal Investigator: Karine Clément, MD INSERM U872
  More Information

No publications provided

Responsible Party: Pileje
ClinicalTrials.gov Identifier: NCT01530685     History of Changes
Other Study ID Numbers: PILEJE-Glyca-0910
Study First Received: December 5, 2011
Last Updated: February 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Pileje:
cinnamon
chromium
prediabete
overweight

Additional relevant MeSH terms:
Hyperglycemia
Prediabetic State
Glucose Metabolism Disorders
 Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013