Contact information
Type
Scientific
Primary contact
Dr Joanna Hlebowicz
ORCID ID
Contact details
Department of Medicine
Malmo University Hospital
Ingang 35
Malmo
205 02
Sweden
+46 (0)40 331000
Joanna.Hlebowicz@skane.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR1004
Study information
Scientific title
Acronym
Study hypothesis
The aim was to study the effect of apple cider vinegar on the rate of gastric emptying on insulin-dependent diabetes mellitus patients with diabetic gastroparesis.
Ethics approval
Not provided at time of registration
Study design
Non-randomised cross over study. Patients are their own controls.
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Gastroparesis, diabetes mellitus type 1 (DM type I)
Intervention
Gastric emptying rate (GER) was measured by standardised real time ultrasonography on the condition that fasting blood glucose was 3.5 to 9.0 mmol/l. Gastric emptying rate was calculated as the percentage change in the antral cross-sectional area 15 and 90 minutes after ingestion of 300 g rice pudding and two decilitres of water or 300 g rice pudding and two decilitres of water and 30 millilitres of apple cider vinegar. The subjects drank 200 ml water daily before breakfast one week before the measurement of GER. The same subjects drank 200 ml with 30 ml vinegar daily before breakfast for two weeks before the measurement of GER.
Intervention type
Drug
Phase
Not Specified
Drug names
Apple cider vinegar
Primary outcome measures
The effect of vinegar on the rate of gastric emptying was statistically significant (p <0.05).
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2002
Overall trial end date
01/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Type 1 diabetes patients with diagnosed gastroparesis
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
10
Participant exclusion criteria
1. Renal failure
2. Prior gastric outlet obstruction
3. Connective tissue diseases
Recruitment start date
01/09/2002
Recruitment end date
01/09/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Medicine
Malmo
205 02
Sweden
Sponsor information
Organisation
Malmo University Hospital (Sweden)
Sponsor details
Department of Medicine
Ingang 35
Malmo
205 02
Sweden
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Malmo Diabetes Association (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary