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

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

Sponsors

Lead sponsor: Attikon Hospital

Collaborator: Hellenic National Diabetes Center

Source Attikon Hospital
Brief 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.

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.

Overall Status Completed
Start Date July 2008
Completion Date December 2014
Primary Completion Date December 2013
Phase N/A
Study Type Interventional
Primary 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
Measure Time Frame
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
Number of participants with adverse events 300 min postmeal
Enrollment 20
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Vinegar

Description: 0,50mmol vinegar (6% acetic acid)

Arm group label: Vinegar

Intervention type: Other

Intervention name: Placebo

Description: 50 ml water

Arm group label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
George D Dimitriadis, Professor Study Director Attikon Hospital
Verification Date

December 2014

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Attikon Hospital

Investigator full name: Panayota Mitrou

Investigator title: Senior Researcher, MD, PhD

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Vinegar

Arm group type: Active Comparator

Description: 0,50mmol vinegar (6% acetic acid)

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: 50 ml water

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov