Assessment of Gastro-Intestinal Function to a Mixed Meal by Non-invasive Imaging
Pilot Study: Assessment of Gastric Motor and Sensory Function to a Mixed Liquid and Solid Test Meal by Gamma Scintigraphy, Magnetic Resonance Imaging and a Nutrient Drink Test in Health and Patients With Disorders of Gastric Function
Dyspeptic symptoms, such as pain after eating, bloating and nausea all have major impact on quality of life and health care costs. When no structural cause is identified, patients are diagnosed with functional dyspepsia. This trial aims to identify objective abnormalities of stomach function that explain patient's symptoms and establish diagnosis. Another group are diabetic patients who can often develop similar symptoms, labelled as diabetic gastroparesis. In some cases this is associated with delayed gastric emptying but not all.
24 patients with functional dyspepsia will be studied and 24 healthy controls (to establish normal ranges) and 24 diabetic patients with symptoms of functional dyspepsia.
The utility of 3 different non-invasive investigations will be assessed. At screening the nutrient drink test (NDT) asks the patient to drink 40ml of milkshake (0.75kcal/ml) every minute and score symptoms every 5 minutes. The patient continues until they reach the maximum tolerated volume.
Participants will then be randomized to undergo non-invasive imaging on two separate test days by magnetic resonance imaging (MRI) and gastric scintigraphy MRI will be completed with the patient ingesting 400ml of milkshake (identical to NDT) and 12 agar beads (no additional calories) of known breaking strength. The emptying of the stomach will be visualised with the MRI alongside symptom recording.
Gamma scintigraphy will ingest the same meal as for the MRI scan but radioactive labelling will allow the rate of liquid and solid meal emptying to be visualised alongside symptom recording.
Additionally, blood sugars will be recorded before nutrient drink test and at 15 and 30 minutes following ingestion of 400ml of milkshake and 12 agar beads.
Data will be analyzed to assess the association of objective abnormalities of gastric function and patient symptoms. Additionally the results of non-invasive imaging by MRI and GS will be compared to assess the optimal measurement of gastric function and emptying in this clinical scenario.
調査の概要
状態
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Nottingham、イギリス、NG7 2YH
- National Institute of Health Research Biomedical Research Unit, Nottingham Digestve Diseases Centre, University of Nottingham,
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Be an adult patient above 18 years old
- Have a body mass index of >18 and <30kg.m2 and not exceed a waist circumference of 99cm at 5cm above ileal crest
- Be able to give voluntary informed consent and from whom written consent to participate has been obtained.
- Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments.
- Be willing to abstain from alcohol for 24 hours before and during the imaging appointment.
- Be willing to fast from midnight prior to the screening and imaging appointment
- Be able to ingest at least 400ml nutrient liquid (0.75kcal/ml at 40ml/min) during a Nutrient Drinking Test without experiencing more than moderate dyspeptic symptoms (no such restriction for patients with dyspeptic symptoms)
- Be able to swallow a solid agar bead between 7.5 and 11.5 mm in diameter
- Be willing to consent to their General Practitioner (GP) being informed of their participation.
Exclusion Criteria:
- Have a history of gastrointestinal disease or surgery (other than appendicitis or hysterectomy)
- Have ongoing disease requiring active management (including impaired renal clearance GFR <50 mL/min/1.73 m2)
- Have a documented history of alcohol or drug abuse
- Fail to satisfy the investigator's assessment of fitness to participate based on a survey of inclusion and exclusion criteria
- Have consumed alcohol within 24 hours of start of study
- Have participated in a similar study involving the use of radioisotopes in the previous 3 months such that participating in the current study would exceed the recommended yearly exposure limit (5mSv)
- Take any medication which may affect oesophageal or gastric motility for a minimum 7 days
- Have had previous history of gastric surgery
- Have active upper gastrointestinal diseases
- Have an active Eating Disorder
- Have an allergy to milk protein (milk based, lactose free test meal)
- Be a vegan
- Be pregnant or breastfeeding
- Have any contraindication to MRI scanning according to local guidelines
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum volume ingested at nutrient drink test (ml)
時間枠：Study Day
|
Maximum of milkshake ingested at maximum satiety
|
Study Day
|
|
Gastric emptying rate (ml/min) for liquids
時間枠：Study day
|
gastric emptying rate measured by non-invasive imaging
|
Study day
|
|
Gastric emptying rate (ml/min) for solids
時間枠：Study Day
|
Gastric emptying rate measured by non-invasive imaging
|
Study Day
|
|
Time taken for 50% gastric emptying (T50, minutes) for liquids
時間枠：Study day-After 50% of contents of stomach has emptied
|
time taken for 50% of gastric contents to leave the stomach
|
Study day-After 50% of contents of stomach has emptied
|
|
Time take for 50% gastric emptying (T50, minutes) solids
時間枠：Study day-after 50% of contents of stomach has emptied
|
Time taken for 50% of gastric contents to leave the stomach
|
Study day-after 50% of contents of stomach has emptied
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sensation at 200ml, 400ml and at completion of nutrient drink test (fullness, bloating, nausea, heartburn, epigastric pain)
時間枠：Study day
|
Visual analogue score for each sensation (score up to 100 points)
|
Study day
|
|
Glycaemic response at 15 minutes and 30 minutes post 400ml milkshake
時間枠：study day
|
Blood glucose (mmol/l)
|
study day
|
|
Gastric volume at 200ml nutrient ingestion
時間枠：Study day
|
Measurement of gastric volume (ml) on MRI and gamma scintigraphy
|
Study day
|
|
Gastric volume at 400ml nutrient ingestion
時間枠：study day
|
measurement of gastric volume (ml) on MRI and gamma scintography
|
study day
|
|
Gastric contractile wave contractile frequency
時間枠：study day
|
contractile frequency within stomach
|
study day
|
|
Oro-caecal Transit time
時間枠：study day
|
Time taken for 50% gastric contents to enter caecum
|
study day
|
|
Sensation threshold volume for fullness, bloating, nausea, heartburn and epigastric pain
時間枠：study day
|
Gastric volume recorded at time of maximum symptom scores
|
study day
|
|
Sensation at 200ml and 400ml ingestion of test meal (fullness, bloating, nausea, heartburn, epigastric pain)
時間枠：study day
|
Visual analogue score for each sensation (score up to 100 points)
|
study day
|
|
GI Hormone Assessment
時間枠：Study day
|
5 ml of blood will be taken at time 0, 30, 60 and 120 min.
GI peptide hormones will then be analysed from the samples.
|
Study day
|
協力者と研究者
捜査官
- 主任研究者：Mark Fox, BMBS, MD、University of Nottingham
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。