Type 2 Diabetes Mellitus
Conditions
Brief summary
The main objective of this study is to assess the acute effect of co-ingested vinegar on postprandial plasma glucose levels in type 2 diabetes patients.
Detailed description
Plasma glucose and insulin concentrations are assessed over the 2 hr period following ingestion of carbohydrate-rich beverage with or without added vinegar.
Interventions
DIETARY_SUPPLEMENTplacebo co-ingestion
25 ml water co-ingested with a glucose-containing beverage
DIETARY_SUPPLEMENTvinegar co-ingestion
25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* male type 2 diabetes * overweight or obese * 40-70 yrs
Exclusion criteria
* incident cardiovascular events during last year * peptic ulcer, duodenal ulcer, oesophageal reflux * antacids, H2 receptor blocker, proton pump inhibitors, NSAIDS, prokinetic agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Glycemic Incremental Area Under the Curve | 2 hr | area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages |
Countries
Netherlands
Participant flow
Recruitment details
recruitment by advertisements in local newspaper
Pre-assignment details
none applicable
Participants by arm
| Arm | Count |
|---|---|
| Vinegar Co-ingestion All participants performed both intervention periods. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Vinegar Co-ingestion |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age Continuous | 65 years STANDARD_DEVIATION 4 |
| Region of Enrollment Netherlands | 12 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Postprandial Glycemic Incremental Area Under the Curve
area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages
Time frame: 2 hr
Population: all subjects completed study and are included in analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vinegar Co-ingestion | Postprandial Glycemic Incremental Area Under the Curve | 739 mmol/L / 2hr | Standard Error 74 |
| Placebo Co-ingestion | Postprandial Glycemic Incremental Area Under the Curve | 759 mmol/L / 2hr | Standard Error 75 |