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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Vinegar; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Vinegar; 0,50mmol vinegar (6% acetic acid)	Dietary supplement: Vinegar; 0,50mmol vinegar (6% acetic acid)
PLACEBO_COMPARATOR: Placebo; 50 ml water	Other: Placebo; 50 ml water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	300 min postmeal
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Collaborators: Hellenic National Diabetes Center
• Investigators: Study Director: George D Dimitriadis, Professor, Attikon Hospital

Publications and helpful links

General Publications

• Mitrou P, Petsiou E, Papakonstantinou E, Maratou E, Lambadiari V, Dimitriadis P, Spanoudi F, Raptis SA, Dimitriadis G. Vinegar Consumption Increases Insulin-Stimulated Glucose Uptake by the Forearm Muscle in Humans with Type 2 Diabetes. J Diabetes Res. 2015;2015:175204. doi: 10.1155/2015/175204. Epub 2015 May 6.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (ESTIMATE): December 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance; Anti-Infective Agents; Anti-Bacterial Agents; Acetic Acid
• Other Study ID Numbers: 167/11-06-08