Clinical trial NCT02309424: The Effect of Vinegar on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Tolerance or Type 2 Diabetes
Official title: The Effect of Vinegar on Glucose and Lipid Metabolism in Peripheral Tissues in Subjects With Impaired Glucose Tolerance or Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
Collaborators: name: Hellenic National Diabetes Center
First posted: 2014-12-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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

Primary outcomes:
measure: Muscle glucose uptake following meal ingestion (area under the glucose uptake versus time curve-AUC)
timeFrame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Secondary outcomes:
measure: Plasma glucose levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
timeFrame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
measure: Plasma insulin levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
timeFrame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
measure: Plasma triglyceride levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
timeFrame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
measure: Plasma NEFA levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
timeFrame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
measure: Plasma glycerol levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
timeFrame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
measure: Muscle blood flow following meal ingestion (area under the blood flow rates versus time curve-AUC)
timeFrame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
measure: Number of participants with adverse events
timeFrame: 300 min postmeal
Other outcomes:
Locations:
Study officials:
affiliation: Attikon Hospital
name: George D Dimitriadis, Professor
role: STUDY_DIRECTOR
References:
citation: 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.