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