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Gycabiane and Glycemic Control of Prediabetic Subjects

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ClinicalTrials.gov Identifier: NCT01530685
Recruitment Status : Unknown
Verified February 2012 by Pileje.
Recruitment status was:  Recruiting
First Posted : February 10, 2012
Last Update Posted : February 10, 2012
Sponsor:
Information provided by (Responsible Party):
Pileje

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

Condition or disease Intervention/treatment Phase
Hyperglycemia Dietary Supplement: Glycabiane Dietary Supplement: placebo Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects
Study Start Date : November 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Glycabiane, gelule Dietary Supplement: Glycabiane
2 gelule per day for 4 months
Other Name: Dietary supplement
Placebo Comparator: Placebo Dietary Supplement: placebo
2 gelules per day for 4 months


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pileje
ClinicalTrials.gov Identifier: NCT01530685     History of Changes
Other Study ID Numbers: PILEJE-Glyca-0910
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012

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