Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
13/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.hand.mas.lu.se/malmo_unv_hosp.htm

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

Publication citations

Additional files

Editorial Notes