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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Pinitol

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Age range of 18-70 years.
Normal fasting glucose subjects were diagnosed as fasting glucose <100 mg/dl and HbA1c <5.7%.
Impaired fasting glucose subjects were diagnosed as fasting glucose between 100 and 125 mg/dl and/or HbA1c between 5.7 and 6.4%.
Type 2 Diabetes subjects were diagnosed as basal plasma glucose ≥ 126 mg/dl, at least twice, or glucose levels 2 hours after 75 g oral glucose overload ≥ 200 mg/dl (American Diabetes Association)

Exclusion criteria:

Morbid obesity
Type 1 diabetes
Heart, liver, thyroid or kidney untreated disease
Neoplasic disease
Hypertriglyceridemia (Triglycerides >400 mg/dl),
Use of drugs that can influence the inflammatory state or insulin sensitivity (NSAIDs, corticosteroids, antiTNFα) and
Uncontrolled type 2 diabetes (HbA1c ≥ 8%) or with insulin or intestinal disaccharidase inhibitors (acarbose, miglyol,...) treatment.

Sites / Locations

University Hospital Dr Peset

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Normal fasting glucose subjects

Impaired fasting glucose subjects

Diabetic subjects

Arm Description

Before pinitol/placebo administration a four weeks run-in period of a healthy diet will be follow for all subjects. After this adaptation period, each subject will be randomized (1:1) into one of two groups: one that received the pinitol-enriched beverage (4 g/day) (n=20), and the other a placebo beverage (n=20) for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To evaluate lipid parameters before and after pinitol/placebo administration

Total cholesterol and triglycerides were measured by means of enzymatic assays and HDL cholesterol concentrations were recorded using a direct method with an autoanalyzer. LDL cholesterol concentration was calculated using the Friedewald method. Non-HDL cholesterol concentration was obtained by calculating the difference between total and HDL cholesterol. Atherogenic index of plasma was obtained by calculating the logarithm of the ratio of plasma concentration of triglycerides to HDL-cholesterol. Apolipoprotein A-I and B were determined by immunonephelometry. These parameters were measured at baseline, 6 and 12 weeks after pinitol/placebo administration.

To evaluate inflammatory parameters before and after pinitol/placebo administration

The evaluation of the inflammatory state was assessed by determination of the concentrations of high sensitive C-reactive protein (hsCRP)(by a latexenhanced immunonephelometric assay) and interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-α) by xMAP Multiplex technology on the Luminex. These parameters were measured at baseline, 6 and 12 weeks after pinitol/placebo administration.

To evaluate endothelial function before and after pinitol/placebo administration

E-selectin, ICAM-1 and VCAM-1 were measured by xMAP Multiplex technology on the Luminex at baseline, 6 and 12 weeks after pinitol/placebo administration

To evaluate oxidative stress on mitochondrial function before and after pinitol/placebo administration

Mitochondrial production of reactive oxygen species, levels of calcium, mitochondrial membrane potential and mitochondrial activity were measured at baseline, 6 and 12 weeks after pinitol/placebo administration

Full Information

NCT ID

NCT01754792

First Posted

December 13, 2012

Last Updated

October 27, 2014

Sponsor

University of Valencia

1. Study Identification

Unique Protocol Identification Number

NCT01754792

Brief Title

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

Official Title

A Randomized, Double-blind, Placebo-controlled Study on the Influence of Pinitol on Carbohydrate, Lipid and Inflammatory Parameters, Endothelial Function and Oxidative Stress in Diabetic, Impaired and Normal Fasting Glucose Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Valencia

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study was to assess whether pinitol improves hidrocarbonated metabolism parameters, and evaluate its effect on oxidative stress and endothelial function in diabetic, impaired and normal fasting glucose subjects. This was a 3-month randomised, controlled-placebo, parallel trial with a three-arm design. Patients were divided into three groups: diabetic (n=40), impaired fasting glucose (n=40) or normal fasting glucose subjects (n=40), receiving 4 g/day of pinitol/placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Impaired Glucose Tolerance, Healthy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal fasting glucose subjects

Arm Type

Experimental

Arm Description

Before pinitol/placebo administration a four weeks run-in period of a healthy diet will be follow for all subjects. After this adaptation period, each subject will be randomized (1:1) into one of two groups: one that received the pinitol-enriched beverage (4 g/day) (n=20), and the other a placebo beverage (n=20) for 12 weeks.

Arm Title

Impaired fasting glucose subjects

Arm Type

Experimental

Arm Description

Before pinitol/placebo administration a four weeks run-in period of a healthy diet will be follow for all subjects. After this adaptation period, each subject will be randomized (1:1) into one of two groups: one that received the pinitol-enriched beverage (4 g/day) (n=20), and the other a placebo beverage (n=20) for 12 weeks.

Arm Title

Diabetic subjects

Arm Type

Experimental

Arm Description

Before pinitol/placebo administration a four weeks run-in period of a healthy diet will be follow for all subjects. After this adaptation period, each subject will be randomized (1:1) into one of two groups: one that received the pinitol-enriched beverage (4 g/day) (n=20), and the other a placebo beverage (n=20) for 12 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Pinitol

Other Intervention Name(s)

3-O-methyl-D-chiro-inositol

Intervention Description

Fruit Up® (diluted with mineral water to a final volume of 250 ml) will be evaluated, and will be equivalent to an intake of 2 g of pinitol. The placebo beverage will contain equal amounts of non-polyol carbohydrates with similar macronutrient composition and energy intake as that those obtained through the pinitol beverage, but excluding pinitol.

Primary Outcome Measure Information:

Title

To assess hidrocarbonated metabolism parameters before and after pinitol/placebo administration

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

To evaluate lipid parameters before and after pinitol/placebo administration

Description

Total cholesterol and triglycerides were measured by means of enzymatic assays and HDL cholesterol concentrations were recorded using a direct method with an autoanalyzer. LDL cholesterol concentration was calculated using the Friedewald method. Non-HDL cholesterol concentration was obtained by calculating the difference between total and HDL cholesterol. Atherogenic index of plasma was obtained by calculating the logarithm of the ratio of plasma concentration of triglycerides to HDL-cholesterol. Apolipoprotein A-I and B were determined by immunonephelometry. These parameters were measured at baseline, 6 and 12 weeks after pinitol/placebo administration.

Time Frame

3 months

Title

To evaluate inflammatory parameters before and after pinitol/placebo administration

Description

The evaluation of the inflammatory state was assessed by determination of the concentrations of high sensitive C-reactive protein (hsCRP)(by a latexenhanced immunonephelometric assay) and interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-α) by xMAP Multiplex technology on the Luminex. These parameters were measured at baseline, 6 and 12 weeks after pinitol/placebo administration.

Time Frame

3 months

Title

To evaluate endothelial function before and after pinitol/placebo administration

Description

E-selectin, ICAM-1 and VCAM-1 were measured by xMAP Multiplex technology on the Luminex at baseline, 6 and 12 weeks after pinitol/placebo administration

Time Frame

3 months

Title

To evaluate oxidative stress on mitochondrial function before and after pinitol/placebo administration

Description

Mitochondrial production of reactive oxygen species, levels of calcium, mitochondrial membrane potential and mitochondrial activity were measured at baseline, 6 and 12 weeks after pinitol/placebo administration

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Age range of 18-70 years. Normal fasting glucose subjects were diagnosed as fasting glucose <100 mg/dl and HbA1c <5.7%. Impaired fasting glucose subjects were diagnosed as fasting glucose between 100 and 125 mg/dl and/or HbA1c between 5.7 and 6.4%. Type 2 Diabetes subjects were diagnosed as basal plasma glucose ≥ 126 mg/dl, at least twice, or glucose levels 2 hours after 75 g oral glucose overload ≥ 200 mg/dl (American Diabetes Association) Exclusion criteria: Morbid obesity Type 1 diabetes Heart, liver, thyroid or kidney untreated disease Neoplasic disease Hypertriglyceridemia (Triglycerides >400 mg/dl), Use of drugs that can influence the inflammatory state or insulin sensitivity (NSAIDs, corticosteroids, antiTNFα) and Uncontrolled type 2 diabetes (HbA1c ≥ 8%) or with insulin or intestinal disaccharidase inhibitors (acarbose, miglyol,...) treatment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio Hernandez, MD, Phd

Organizational Affiliation

Universtiy of Valencia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Dr Peset

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Type 2 Diabetes, Impaired Glucose Tolerance, Healthy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial