Gastric Emptying: in Vivo Studies in Healthy Volunteers

2016-12-15 19:53:21 | BioPortfolio


The Investigators institution has used a meal consisting of mashed potato, peas and Beanfeast (soya mince) for gastric emptying studies for a number of decades. Validation of the study method was purportedly performed when the study was first implemented at the hospital, however no historical data has been found. The current normal ranges are also unsubstantiated. There is scientific justification for this research because in vivo studies are instrumental to the validation of a new procedure. There is a need for a meal preparation that is palatable and meets dietary requirements (vegetarian, gluten free e.t.c.) of patients as the diagnosis depends on ingestion of the radiolabelled meal. In addition, reliable normal ranges will ensure that the clinical diagnosis is accurate. Scientific justification extends beyond the local department as publishing the data acquired will allow other hospitals to adopt the same test meals and normal ranges, leading to standardisation of the clinical protocol employed across the UK. Since the investigators institution are recognised as the leading Nuclear Medicine GI centre in the UK and have previously carried out audits and in vitro testing in the area of gastric emptying, it seems fit that they should lead the national change in protocol.

The proposed study will involve recruitment of healthy volunteers who will eat a meal containing 10MBq of a radioactive tracer. They will be subsequently scanned using a gamma camera with imaging lasting no more than 3 hours in total. Approximately 40 healthy volunteers (18-70 years old, no history of gastrointestinal problems or other serious health issues e.g. diabetes and pregnant women are excluded) will be recruited and the studies will be conducted on site i.e. within the Nuclear Medicine department at City hospital.


After the ingestion and subsequent passage of solid or liquid material into the stomach, the gastric contents will undergo gastric emptying from the stomach into the intestine. The rate of gastric emptying can be very variable and will depend on the presence of gastric pathology or defect, composition and volume of the gastric contents and may even be influenced by factors such as gender and reproductive status. Gastric motility disorders such as gastroparesis and dumping syndrome can affect the rate of gastric emptying and thus warrant the quantitative assessment of emptying. Gastroparesis is a disorder of the stomach characterised by delayed gastric emptying in the absence of any mechanical obstruction and can be further categorised based on severity; mild gastroparesis (where symptoms can be easily controlled), compensated gastroparesis (partial control with use of medication and dietary adjustments) and gastric failure (symptoms are not controllable). Dumping syndrome occurs as a result of rapid gastric emptying which is usually associated with hypermotility of the stomach. It manifests as either early or late dumping syndrome, both of which have distinct physiological bases and clinical presentations.

Typical symptoms of delayed emptying include nausea, vomiting, abdominal pain and abdominal fullness after eating whilst diarrhoea, weakness and light headedness after meal times are common symptoms of rapid emptying. In the Nuclear Medicine department at City Hospital (Birmingham), patients referred for imaging are usually diabetics suffering from feelings of bloatedness after eating and occasional vomiting. Most patients studied are clinically diagnosed with gastroparesis associated with diabetes (where the vagus nerve responsible for controlling movement of food through the digestive tract stops functioning). Dumping is rarely reported as there is an effective tablet treatment for the disorder that usually eases the symptoms. (This includes octreotide therapies which can exert an effect through various mechanisms such as delaying transit, inhibiting the release of gut peptides and impaired fluid secretion). If left untreated gastroparesis can make diabetes worse by making it more difficult to manage blood glucose. Assessment of gastric emptying rate is therefore an important part of diagnosis.

Gastric emptying scintigraphy is a non-invasive diagnostic tool that is used in Nuclear Medicine to study the emptying of contents into the stomach. This form of scintigraphic examination is reproducible, simple to perform, accurate, quantitative and exposes the patient to only a very small radiation dose. It has been significantly optimised and refined over the years and is now well established as the standard method for evaluating gastric emptying. As the 'gold standard' gastric emptying scintigraphy is usually the first stage of the diagnostic journey for a patient, although some may have had a prior endoscopy (usually in cases of severe vomiting).

The procedure is known to vary between institutions, however will usually involve binding of a radiotracer to a solid or liquid meal which is then administered orally. This is followed by positioning of the patient in front of a camera and continuous or intermittent imaging is performed. Data is acquired over a length of time (usually 1-2 hours) and the data subsequently analysed to determine the half emptying time (i.e. the time required for the stomach to empty 50% of the ingested meal) which is then compared to established normal ranges (i.e. normal emptying rate expected for healthy individual). The current radioactive meal used for the study consisting of mashed potato, peas and Beanfeast (soya mince) is not particularly palatable, does not meet the dietary requirements of some patients (e.g. gluten/wheat free) and is difficult to prepare. In addition, in-house in vitro studies have found the current meal to be inferior to other meal preparations. Subjecting the radioactive meal to simulated conditions of the stomach has found that the radiolabel retention was significantly better in other meals such as scrambled egg and porridge.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Gastric Disease


Gastric emptying scintigraphy using 99mTc-DTPA


Not yet recruiting


Sandwell & West Birmingham Hospitals NHS Trust

Results (where available)

View Results


Published on BioPortfolio: 2016-12-15T19:53:21-0500

Clinical Trials [1849 Associated Clinical Trials listed on BioPortfolio]

Bariatric Procedures and Changes in Incretins and Gastric Emptying

The study evaluates the gastric emptying by scintigraphy in patients that had bariatric surgery (RYGB of gastric sleeve) comparing patients with successful and unsuccessful weight loss and...

Gastric Emptying in Elderly With Hip Fracture

The gastric emptying of 400 ml 12.6% carbohydrate rich drink is investigated in elderly women, age 75-100, with acute hip fracture. The emptying time will be assessed by the paracetamol ab...

Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.

This study will use scintigraphy techniques to measure gastric emptying rate of liquid and solid food at baseline and after administration of GSK716155 or placebo.

Gastric Emptying Time of a Rice-based Meal

Adequate preoperative fasting is critical in preventing pulmonary aspiration of gastric content. Ultrasonography is considering as a useful test assessing the volume of gastric contents, b...

Effect of Protein Composition on Gastric Emptying

The protein composition of nutrition may affect the rate of gastric emptying and gastric fysiology. This is espesially important in children with neurologic impariment, who commonly rely ...

PubMed Articles [15670 Associated PubMed Articles listed on BioPortfolio]

Simultaneous Blood Glucose Monitoring During Gastric-Emptying Scintigraphy May Identify Unsuspected Abnormalities.

A retrospective study of 197 patients was performed to evaluate utility of simultaneous fingerstick glucose monitoring during standardized solid meal gastric-emptying scintigraphy (GES). We hypothesiz...

A prospective study comparing 99mTc-MIBI and 99mTc-MDP with 99mTc-DTPA for lung ventilation scintigraphy in pulmonary thromboembolism.

The aim of the study was to assess the efficacy of technetium 99m-methyl diphosphonate (Tc-MDP) and technetium 99m-methoxyisobutylisonitrile (Tc-MIBI) as radioaerosol alternatives to technetium 99m-di...

Roux-en-Y duodenojejunostomy improves gastric emptying in experimental obstruction of the distal duodenum.

We undertook a comparative survey of gastric emptying (GE) kinetics after two variants of bypass surgery for upper bowel obstruction.

Gastric Emptying Impacts the Timing of Meal Glucose Peak on Subjects with Uncomplicated Type 1 Diabetes.

Diabetes mellitus (DM) is associated with gastrointestinal (GI) motility dysfunction, ranging from delayed to accelerated gastric emptying (GE).

A Higher Preoperative Glycemic Profile Is Associated with Rapid Gastric Emptying After Sleeve Gastrectomy for Obese Subjects.

Recent reports have shown that sleeve gastrectomy (SG) accelerates gastric emptying (GE), but the etiology remains unclear. This study aimed to investigate the factors affecting GE before and after SG...

Medical and Biotech [MESH] Definitions

Abnormal distention of the STOMACH due to accumulation of gastric contents that may reach 10 to 15 liters. Gastric dilatation may be the result of GASTRIC OUTLET OBSTRUCTION; ILEUS; GASTROPARESIS; or denervation.

Vagal denervation of that part of the STOMACH lined with acid-secreting mucosa (GASTRIC MUCOSA) containing the GASTRIC PARIETAL CELLS. Since the procedure leaves the vagal branches to the antrum and PYLORUS intact, it circumvents gastric drainage required with truncal vagotomy techniques.

Rounded or pyramidal cells of the GASTRIC GLANDS. They secrete HYDROCHLORIC ACID and produce gastric intrinsic factor, a glycoprotein that binds VITAMIN B12.

The evacuation of food from the stomach into the duodenum.

A 36-amino acid pancreatic hormone that is secreted mainly by endocrine cells found at the periphery of the ISLETS OF LANGERHANS and adjacent to cells containing SOMATOSTATIN and GLUCAGON. Pancreatic polypeptide (PP), when administered peripherally, can suppress gastric secretion, gastric emptying, pancreatic enzyme secretion, and appetite. A lack of pancreatic polypeptide (PP) has been associated with OBESITY in rats and mice.

More From BioPortfolio on "Gastric Emptying: in Vivo Studies in Healthy Volunteers"

Quick Search


Relevant Topics

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial