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Completed

NCT Number: NCT02309424

The Effect of Vinegar on Glucose and Lipid Metabolism 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with impaired glucose tolerance or newly diagnosed type 2 diabetes before the initiation of medication therapy
  • Recreationally active
  • With stable body weight and diet during the last two months.

Exclusion criteria

  • Any systemic disease (besides glucose abnormalities)
  • Any medication therapy
  • Diabetic complications

Treatment and study plan

Vinegar

Dietary Supplement

0,50mmol vinegar (6% acetic acid)

Placebo

Other

50 ml water

Primary outcomes

  1. Muscle glucose uptake following meal ingestion (area under the glucose uptake versus time curve-AUC)

    Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal

Secondary outcomes

  1. Plasma glucose levels following meal ingestion (area under the plasma concentration versus time curve-AUC)

    Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  2. Plasma insulin levels following meal ingestion (area under the plasma concentration versus time curve-AUC)

    Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  3. Plasma triglyceride levels following meal ingestion (area under the plasma concentration versus time curve-AUC)

    Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  4. Plasma NEFA levels following meal ingestion (area under the plasma concentration versus time curve-AUC)

    Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  5. Plasma glycerol levels following meal ingestion (area under the plasma concentration versus time curve-AUC)

    Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  6. Muscle blood flow following meal ingestion (area under the blood flow rates versus time curve-AUC)

    Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  7. Number of participants with adverse events

    Time frame: 300 min postmeal

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Collaborators

  • Hellenic National Diabetes Center

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Dec 5, 2014
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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