|- candidate number||2644|
|- NTR Number||NTR1004|
|- Date ISRCTN created||23-aug-2007|
|- date ISRCTN requested||13-aug-2007|
|- Date Registered NTR||29-jun-2007|
|- Secondary IDs|| |
|- Public Title||Effect of apple cider vinegar on delayed gastric emptying in people with type 1 diabetes mellitus.|
|- Scientific Title||Effect of apple cider vinegar on delayed gastric emptying in people with type 1 diabetes mellitus.|
|- 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.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 1 (DM type I), Gastroparesis, Apple cider vinegar|
|- Inclusion criteria||Type 1 diabetes patienets with diagnosed gastroparesis were included in the study.|
|- Exclusion criteria||1. Renal failure;|
2. Prior gastric outlet obstruction;
3. Connective tissue diseases.
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-sep-2002|
|- planned closingdate||1-sep-2005|
|- Target number of participants||10|
|- Interventions||Gastric emptying rate (GER) was measured by standardized 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.|
|- Primary outcome||The effect of vinegar on the rate of gastric emptying was statistically significant (p <0.05). |
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. Joanna Hlebowicz|
|- CONTACT for SCIENTIFIC QUERIES||MD. Joanna Hlebowicz|
|- Sponsor/Initiator ||Malmö University Hospital|
(Source(s) of Monetary or Material Support)
|Malmö diabetes association Sweden|
|- Publications||BMC Gastroenterol. 2007 Dec 20;7:46.
This study is one of five studies for a PhD graduation. One of the studies has been publicatied by The American Journal of Clinical Nutrition.
|- Brief summary||Diabetes mellitus is a growing problem globally and according to Swedish national guidelines does it affect 3-4 % (300000- 350000) of the Swedish population. Studies have shown that 30-50 % of diabetes patients have a delayed gastric emptying and this is believed to be, at least partially, due to vagal denervation caused by autonomic neuropathy. Delayed gastric emptying may cause poor glycemic control especially in those with preprandial antidiabetic treatment giving postprandial hypoglycaemia and symptoms from the gastro intestinal tract like postprandial nausea, vomiting, bloating and early satiety.|
Studies have shown that vinegar reduces postprandial blood glucose in healthy subjects and it has been discussed whether this could be explained or not by a delayed gastric emptying. However, the effect of vinegar on gastric emptying in diabetic patients with gastroparesis has not been studied previously.
The aim of this study was therefore to evaluate the influence of vinegar on the gastric emptying in insulin-dependent diabetes mellitus patients with diabetic gastroparesis.
|- Main changes (audit trail)|
|- RECORD||29-jun-2007 - 11-sep-2008|