Effects of Glutamine on Gastric Emptying
| Tracking Information | |||||
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| First Received Date ICMJE | July 17, 2009 | ||||
| Last Updated Date | November 15, 2009 | ||||
| Start Date ICMJE | July 2009 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine. [ Time Frame: 4 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00943020 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Glutamine on Gastric Emptying | ||||
| Official Title ICMJE | The Effects of Supplementing Glutamine on the Gastric Emptying Time of a Preoperative Metabolic Conditioning Drink in Healthy Volunteers: a Randomized Crossover Pilot Study | ||||
| Brief Summary | Surgical patients are usually starved for 8 hours before operation in order to ensure the stomach is empty and thus reduce the chances of vomiting during the anaesthetic. Recent studies have shown that this period of starvation is harmful as it 'weakens' the body before operation. To avoid the harmful effects of starvation, patients are now given carbohydrate (sugar-containing) drinks 2 to 4 hours before surgery. These drinks have been shown to make patients feel better, reduce sickness after the anaesthetic/surgery and result in a quicker recovery from operation. The optimum time of giving these drinks to patients before operation is unknown. Previous studies have shown that the drinks empty from the stomach within 2 - 4 hours depending on their ingredients. The investigators would like to study the effects of adding protein and fat to these drinks on how quickly the drinks empty from the stomach. This study will investigate the hormone responses of the body following intake of 3 different drinks in order to determine the mechanisms that underlie the control of stomach emptying. This information will also allow us to improve the design of these drinks and this could help patients who undergo surgery who receive them. |
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| Detailed Description | The eligibility criteria for this study are as follows: Interested participants will be asked to attend a screening interview during which the study procedures/risks/benefits will be explained, followed by a brief history and physical examination. If deemed necessary by the study investigator, a 7ml sample of blood will be taken for screening purposes. The volunteer will be deemed eligible for the study once they have passed the screening visit and [when performed] had normal screening blood investigation results. Each volunteer will be studied 3 times, the order of which will be determined randomly by computer. Participants will report for the study at the Division of GI Surgery (E−floor, West Block, Queen's Medical Centre), at 7:15am. On arrival the subject's height and weight will be recorded and 'drip needle' will will be placed in the back of the wrist. The hand will be rested in a hand−heater allowing venous blood to be sampled. The subject will be randomly allocated to receive one of the three study drinks. At 7:50am baseline blood will be sampled (10ml [1.5 tablespoons] via the drip needle). At 8am the volunteers will drink the study drink. The rate of stomach emptying will be measured by using Gamma scintigraphy (a specialised medical camera). The drinks will have added a tracer substance that is visible on the camera and allows us to follow drink as it passes through the stomach into the bowels. Each 'picture' of the stomach lasts 20 seconds and we plan to take these every 20 minutes for 4 hours after intake of the drink. At 20 minute intervals (until 220 mins have elapsed) 7ml (1 tablespoon) of blood will be sampled via the drip needle. The final 10 ml blood sample will be taken at 240 minutes following which the drip needle will be removed and the volunteers will be allowed home. The subsequent two studies will be performed 7 days following the first study. In total 95ml (a sixth of a pint) blood will be taken during each of the 3 crossover studies which will be separated by a period of 7 days (i.e. a total of 285 ml [half a pint] blood will be required from each volunteer). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science |
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| Condition ICMJE | Starvation | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 15 | ||||
| Completion Date | November 2009 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00943020 | ||||
| Other Study ID Numbers ICMJE | 09026 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Mr Dileep N Lobo, University of Nottingham | ||||
| Study Sponsor ICMJE | University of Nottingham | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Nottingham | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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