Clinical TrialID 3553

Effects of Pinitol on Hidrocarbonated Metabolism Parameters in Diabetic, Impaired and Normal Fasting Glucose Subjects

NCT01754792

Type 2 Diabetes|Impaired Glucose Tolerance|Healthy

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
3553
Evidence Id
3553
Core Evidence Id
3553
Source Clinical Trial Id
3527
Herb2 Clinical Trial Id
HBCT003527
Nct Id
NCT01754792
Title
Effects of Pinitol on Hidrocarbonated Metabolism Parameters in Diabetic, Impaired and Normal Fasting Glucose Subjects
Status
Completed
Phase
Study Result
No
Study Condition
Type 2 Diabetes|Impaired Glucose Tolerance|Healthy
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Intervention
DIETARY_SUPPLEMENT: Pinitol
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Prevention
Gender
All
Age
Adult, Older_Adult
Enrollment
120
Outcome Measure
To assess hidrocarbonated metabolism parameters before and after pinitol/placebo administration, Blood samples were collected in vacutainer serum separator tubes, after 12- hour overnight fasting, to analyze glucose and insulin concentration at baseline (after a four weeks run-in period of a healthy diet), 6 and 12 weeks after pinitol/placebo administration. Glucose concentrations were measured by means of enzymatic assay in an autoanalyzer. Insulin concentrations were determined by enzyme-linked immunosorbent assay. In a representative group of patients of all groups at time 0 and 10 weeks, a 24 hours glucose levels control were assessed (by means of a continuous glucose monitoring system) for 3 days. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR) index (fasting insulin (μIU/ml) x fasting glucose (mg/dl) /405). Glycosylated hemoglobin (HbA1c) was measured at baseline and 12 weeks in diabetic and impaired fasting glucose subjects., 3 months
Sponsor Collaborator
University of Valencia
Funded By
OTHER
Location
University Hospital Dr Peset, Valencia, 46017, Spain
Other Id
WIL-PIN-2012-02
Start Date
2012-01
Primary Completion Date
2013-06
Completion Date
2013-07
First Posted
2012-12-21
Results First Posted
Last Update Posted
2014-10-28
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01754792
Title Cn
Title En
Effects of Pinitol on Hidrocarbonated Metabolism Parameters in Diabetic, Impaired and Normal Fasting Glucose Subjects
Bilingual Status
semi_complete