The Effect of Vinegar on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Tolerance or Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

The Effect of Vinegar on Glucose and Lipid Metabolism in Peripheral Tissues in Subjects With Impaired Glucose Tolerance or Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309424
• Other study ID #: 167/11-06-08
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: December 4, 2014
• Start date: July 2008
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

This open, randomized, cross-over, placebo-controlled study aims to investigate the effects of vinegar on glucose metabolism, endothelial function and circulating lipid levels in subjects with impaired glucose tolerance or type 2 diabetes, using the arteriovenous difference technique.

Description:

Subjects with IGT or type 2 diabetes will be randomised to consume 20ml vinegar (6% acetic acid) or placebo before a mixed meal. Plasma samples will be taken for 300min from the radial artery and from a forearm vein for measurements of glucose, insulin, triglycerides, non-esterified fatty acids (NEFA) and glycerol. Muscle blood flow will be measured with strain-gauge plethysmography. Glucose flux will be calculated as the arteriovenous difference of glucose multiplied by the blood flow rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subjects with impaired glucose tolerance or newly diagnosed type 2 diabetes before the initiation of medication therapy

2. Recreationally active

3. With stable body weight and diet during the last two months.

Exclusion Criteria:

1. Any systemic disease (besides glucose abnormalities)

2. Any medication therapy

3. Diabetic complications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Vinegar
0,50mmol vinegar (6% acetic acid)

Other:
• Placebo
50 ml water

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Attikon Hospital	Hellenic National Diabetes Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle glucose uptake following meal ingestion (area under the glucose uptake versus time curve-AUC)		0, 30, 60, 90, 120, 180, 240, 300 min postmeal	No
Secondary	Plasma glucose levels following meal ingestion (area under the plasma concentration versus time curve-AUC)		0, 30, 60, 90, 120, 180, 240, 300 min postmeal	No
Secondary	Plasma insulin levels following meal ingestion (area under the plasma concentration versus time curve-AUC)		0, 30, 60, 90, 120, 180, 240, 300 min postmeal	No
Secondary	Plasma triglyceride levels following meal ingestion (area under the plasma concentration versus time curve-AUC)		0, 30, 60, 90, 120, 180, 240, 300 min postmeal	No
Secondary	Plasma NEFA levels following meal ingestion (area under the plasma concentration versus time curve-AUC)		0, 30, 60, 90, 120, 180, 240, 300 min postmeal	No
Secondary	Plasma glycerol levels following meal ingestion (area under the plasma concentration versus time curve-AUC)		0, 30, 60, 90, 120, 180, 240, 300 min postmeal	No
Secondary	Muscle blood flow following meal ingestion (area under the blood flow rates versus time curve-AUC)		0, 30, 60, 90, 120, 180, 240, 300 min postmeal	No
Secondary	Number of participants with adverse events		300 min postmeal	Yes