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Effect of DA-9701 on Gastric Motor Function Assessed by Magnetic Resonance Imaging in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial.

Min YW, Min BH, Kim S, Choi D, Rhee PL - PLoS ONE (2015)

Bottom Line: Changes in TGV and proximal TGV after a meal did not differ between the DA-9701 and placebo groups (difference between groups -25.9 mL, 95% confidence interval [CI] -54.0 to 2.3 mL, P = 0.070 and -2.9 mL, 95% CI -30.3 to 24.5 mL, P = 0.832, respectively).In addition, pre-treatment with DA-9701 significantly increased gastric emptying as compared with placebo (mean difference between groups 3.41%, 95% CI 0.54% to 6.29%, P = 0.021, by mixed model for repeated measures).Our results suggested that DA-9701 enhances gastric emptying and does not significantly affect gastric accommodation in healthy volunteers.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

ABSTRACT

Background: Improving gastric accommodation and gastric emptying is an attractive physiological treatment target in patients with functional dyspepsia (FD). We evaluated the effect of DA-9701, a new drug for FD, on gastric motor function after a meal in healthy volunteers using magnetic resonance imaging (MRI).

Methods: Forty healthy volunteers were randomly allocated to receive either DA-9701 or placebo. After 5 days of treatment, subjects underwent gastric MRI (60 min before and 15, 30, 45, 60, 90, and 120 min after a liquid test meal). Gastric volume was measured through 3-dimensional reconstruction from MRI data. We analyzed 4 outcome variables including changes in total gastric volume (TGV), proximal TGV, and proximal to distal TGV ratio after a meal and gastric emptying rates after adjusting values at the pre-test meal.

Results: Changes in TGV and proximal TGV after a meal did not differ between the DA-9701 and placebo groups (difference between groups -25.9 mL, 95% confidence interval [CI] -54.0 to 2.3 mL, P = 0.070 and -2.9 mL, 95% CI -30.3 to 24.5 mL, P = 0.832, respectively). However, pre-treatment with DA-9701 increased postprandial proximal to distal TGV ratio more than placebo (difference between groups 0.93, 95% CI 0.08 to 1.79, P = 0.034). In addition, pre-treatment with DA-9701 significantly increased gastric emptying as compared with placebo (mean difference between groups 3.41%, 95% CI 0.54% to 6.29%, P = 0.021, by mixed model for repeated measures).

Conclusion: Our results suggested that DA-9701 enhances gastric emptying and does not significantly affect gastric accommodation in healthy volunteers. Further studies to confirm whether DA-9701 enhances these gastric motor functions in patients with FD are warranted.

Trial registration: ClinicalTrials.gov NCT02091635.

No MeSH data available.


Related in: MedlinePlus

Three-dimensional visualization of stomach volumes measured by MRI before (A) and after (B) ingesting the test meal.The stomach was divided into the proximal (orange) and distal stomach (yellow) by an imaginary line (red arrow) drawn from the angular incisures to the point of contact between the 2 longitudinal axes (blue lines) through the center of the upper and lower parts of the stomach. The DA-9701 group case showed an increase in proximal to distal TGV ratio from 1.88 to 4.50 15 min after the test meal.
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pone.0138927.g003: Three-dimensional visualization of stomach volumes measured by MRI before (A) and after (B) ingesting the test meal.The stomach was divided into the proximal (orange) and distal stomach (yellow) by an imaginary line (red arrow) drawn from the angular incisures to the point of contact between the 2 longitudinal axes (blue lines) through the center of the upper and lower parts of the stomach. The DA-9701 group case showed an increase in proximal to distal TGV ratio from 1.88 to 4.50 15 min after the test meal.

Mentions: Gastric MRI was performed in the supine position using a 1.5T system (Interal Achieva, Philips Healthcare, Best, The Netherlands). Unenhanced images were obtained with turbo-field-echo sequence (repetition time, 4.1 ms; echo time, 1.63 ms; slice thickness 5 mm, no overlap, coronal). Thirty (or 35) consecutive slices covering the entire upper abdomen were obtained during 23 (or 25) seconds with one breath-hold (35 slices and 25 seconds were required in some subjects with a relatively large stomach). The areas of interest were drawn around gastric contents and air in each slice on the screen, which was identified by distinct contrast against the surrounding tissues, to determine the area of gastric contents and air. Obtained MRI data were transformed into 3-D images using AZE VirtualPlaceTM (AZE, Ltd., Tokyo, Japan), and gastric contents volume (GCV) was analyzed. Total gastric volume (TGV) was calculated by adding gastric air volume to GCV. The stomach was divided into the proximal and distal stomach using an imaginary line drawn from the angular incisures to the point of contact between the 2 longitudinal axes through the center of the upper and lower parts of the stomach (Fig 3). All areas of interest and imaginary lines dividing the stomach were drawn by co-author D.C. a qualified gastrointestinal radiologist, who was blinded to treatment group but not blinded to time-point and not blinded to patient.


Effect of DA-9701 on Gastric Motor Function Assessed by Magnetic Resonance Imaging in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial.

Min YW, Min BH, Kim S, Choi D, Rhee PL - PLoS ONE (2015)

Three-dimensional visualization of stomach volumes measured by MRI before (A) and after (B) ingesting the test meal.The stomach was divided into the proximal (orange) and distal stomach (yellow) by an imaginary line (red arrow) drawn from the angular incisures to the point of contact between the 2 longitudinal axes (blue lines) through the center of the upper and lower parts of the stomach. The DA-9701 group case showed an increase in proximal to distal TGV ratio from 1.88 to 4.50 15 min after the test meal.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4581730&req=5

pone.0138927.g003: Three-dimensional visualization of stomach volumes measured by MRI before (A) and after (B) ingesting the test meal.The stomach was divided into the proximal (orange) and distal stomach (yellow) by an imaginary line (red arrow) drawn from the angular incisures to the point of contact between the 2 longitudinal axes (blue lines) through the center of the upper and lower parts of the stomach. The DA-9701 group case showed an increase in proximal to distal TGV ratio from 1.88 to 4.50 15 min after the test meal.
Mentions: Gastric MRI was performed in the supine position using a 1.5T system (Interal Achieva, Philips Healthcare, Best, The Netherlands). Unenhanced images were obtained with turbo-field-echo sequence (repetition time, 4.1 ms; echo time, 1.63 ms; slice thickness 5 mm, no overlap, coronal). Thirty (or 35) consecutive slices covering the entire upper abdomen were obtained during 23 (or 25) seconds with one breath-hold (35 slices and 25 seconds were required in some subjects with a relatively large stomach). The areas of interest were drawn around gastric contents and air in each slice on the screen, which was identified by distinct contrast against the surrounding tissues, to determine the area of gastric contents and air. Obtained MRI data were transformed into 3-D images using AZE VirtualPlaceTM (AZE, Ltd., Tokyo, Japan), and gastric contents volume (GCV) was analyzed. Total gastric volume (TGV) was calculated by adding gastric air volume to GCV. The stomach was divided into the proximal and distal stomach using an imaginary line drawn from the angular incisures to the point of contact between the 2 longitudinal axes through the center of the upper and lower parts of the stomach (Fig 3). All areas of interest and imaginary lines dividing the stomach were drawn by co-author D.C. a qualified gastrointestinal radiologist, who was blinded to treatment group but not blinded to time-point and not blinded to patient.

Bottom Line: Changes in TGV and proximal TGV after a meal did not differ between the DA-9701 and placebo groups (difference between groups -25.9 mL, 95% confidence interval [CI] -54.0 to 2.3 mL, P = 0.070 and -2.9 mL, 95% CI -30.3 to 24.5 mL, P = 0.832, respectively).In addition, pre-treatment with DA-9701 significantly increased gastric emptying as compared with placebo (mean difference between groups 3.41%, 95% CI 0.54% to 6.29%, P = 0.021, by mixed model for repeated measures).Our results suggested that DA-9701 enhances gastric emptying and does not significantly affect gastric accommodation in healthy volunteers.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

ABSTRACT

Background: Improving gastric accommodation and gastric emptying is an attractive physiological treatment target in patients with functional dyspepsia (FD). We evaluated the effect of DA-9701, a new drug for FD, on gastric motor function after a meal in healthy volunteers using magnetic resonance imaging (MRI).

Methods: Forty healthy volunteers were randomly allocated to receive either DA-9701 or placebo. After 5 days of treatment, subjects underwent gastric MRI (60 min before and 15, 30, 45, 60, 90, and 120 min after a liquid test meal). Gastric volume was measured through 3-dimensional reconstruction from MRI data. We analyzed 4 outcome variables including changes in total gastric volume (TGV), proximal TGV, and proximal to distal TGV ratio after a meal and gastric emptying rates after adjusting values at the pre-test meal.

Results: Changes in TGV and proximal TGV after a meal did not differ between the DA-9701 and placebo groups (difference between groups -25.9 mL, 95% confidence interval [CI] -54.0 to 2.3 mL, P = 0.070 and -2.9 mL, 95% CI -30.3 to 24.5 mL, P = 0.832, respectively). However, pre-treatment with DA-9701 increased postprandial proximal to distal TGV ratio more than placebo (difference between groups 0.93, 95% CI 0.08 to 1.79, P = 0.034). In addition, pre-treatment with DA-9701 significantly increased gastric emptying as compared with placebo (mean difference between groups 3.41%, 95% CI 0.54% to 6.29%, P = 0.021, by mixed model for repeated measures).

Conclusion: Our results suggested that DA-9701 enhances gastric emptying and does not significantly affect gastric accommodation in healthy volunteers. Further studies to confirm whether DA-9701 enhances these gastric motor functions in patients with FD are warranted.

Trial registration: ClinicalTrials.gov NCT02091635.

No MeSH data available.


Related in: MedlinePlus