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

NCT ID: NCT01754792

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-07-31

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.

Conditions

Type 2 Diabetes; Impaired Glucose Tolerance; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Normal fasting glucose subjects

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.

Group Type: EXPERIMENTAL

Pinitol

Intervention Type: DIETARY_SUPPLEMENT

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.

Impaired fasting glucose subjects

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.

Group Type: EXPERIMENTAL

Pinitol

Intervention Type: DIETARY_SUPPLEMENT

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.

Diabetic subjects

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.

Group Type: EXPERIMENTAL

Pinitol

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Pinitol

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

3-O-methyl-D-chiro-inositol

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Antonio Hernández Mijares

PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Hernandez, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Universtiy of Valencia

Locations

University Hospital Dr Peset

Valencia, , Spain

Countries

Spain

Other Identifiers

WIL-PIN-2012-02

Identifier Type: -

Identifier Source: org_study_id