Effect of apple cider vinegar on delayed gastric emptying in people with type 1 diabetes mellitus

ISRCTN	ISRCTN33841495
DOI	https://doi.org/10.1186/ISRCTN33841495
Secondary identifying numbers	NTR1004

Submission date: 23/08/2007
Registration date: 23/08/2007
Last edited: 31/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Joanna Hlebowicz
Scientific

Department of Medicine
Malmo University Hospital
Ingang 35
Malmo
205 02
Sweden

Phone	+46 (0)40 331000
Email	Joanna.Hlebowicz@skane.se

Study information

Study design	Non-randomised cross over study. Patients are their own controls.
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Effect of apple cider vinegar on delayed gastric emptying in people with type 1 diabetes mellitus
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Apple cider vinegar
Primary outcome measure	The effect of vinegar on the rate of gastric emptying was statistically significant (p <0.05).
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/09/2002
Completion date	01/09/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	10
Total final enrolment	10
Key inclusion criteria	Type 1 diabetes patients with diagnosed gastroparesis
Key exclusion criteria	1. Renal failure 2. Prior gastric outlet obstruction 3. Connective tissue diseases
Date of first enrolment	01/09/2002
Date of final enrolment	01/09/2005

Locations

Countries of recruitment

Netherlands
Sweden

Study participating centre

Department of Medicine

Malmo
205 02
Sweden

Sponsor information

Malmo University Hospital (Sweden)
Hospital/treatment centre

Department of Medicine
Ingang 35
Malmo
205 02
Sweden

Website	http://www.hand.mas.lu.se/malmo_unv_hosp.htm
"ROR"	https://ror.org/02z31g829

Funders

Funder type

Research organisation

Malmo Diabetes Association (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/12/2007	31/12/2020	Yes	No

Editorial Notes

31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.