To compare the effects of two drugs named Acotiamide and Domperidon on the gastrointestinal symptom profile of patients with diabetes.

Active, not recruiting

• Conditions: Type 2 diabetic patients with minimum 5 year duration with symptoms of diabetic gastroparesis

• Registration Number: CTRI/2017/07/009173
• Lead Sponsor: DRUSHA DUTTA

Brief Summary

Treatment with either drug is going to improve blood sugar levels and quality of life in diabetic patients

Patients will be regularly followed up during their one month therapy with either drug. Appearance of any untoward side effect will be taken into serious consideration. Patients will have the liberty to withdraw from the trial at any time.

At the end of one month therapy with either drug, patients will have to undergo repeat evaluation of gastric emptying time, small bowel transit time, gastric antral volume, gall bladder ejection fraction by the same aforementioned methods for comparison of the effects of the drugs.

Previous literature has shown the efficacy of Domperidone in diabetic gastroparesis without any serious side effect.

On the other hand, randomized control trials involving Acotiamide have shown promising results in functional dyspepsia without any significant side effect. Adequate trials in diabetic gastroparesis are awaited.

Assessment  and treatment of diabetic patient for gastroparesis is going to improve there quality of life and blood glucose control, So gastroparesis  requires pharmaceutical interventions for improvement of symptom profile and quality of life

Drugs available for gastroparesis have limited efficacy  ,tachyphylaxis (decreasing response with continued use )  ,and high rate of side effect profile .So there is urgent need of some novel drug bypassing all these limitations . So, if results of Acotiamide are found to be significantly beneficial in our trial, then it can be subjected to further analysis and it may be favourable for the population at large.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-31
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• •Age above 18 years and below 65 years.
• •Documented history of diabetes mellitus (type 2) for a duration of minimum 5 years.
• •HbA1c 7-9gm% •Clinical evidence of gatroparesis with symptoms of post prandial fullness, early satiety, abdominal bloating, nausea, retching, vomiting of undigested food.

Exclusion Criteria

Inability to obtain informed consent Pregnant or lactating women Patient with thyroid dydsfunction,renal failure ,parkinsons disease ,scleroderma Drug or alcohol abuse UGIE showing any mechanical obstruction Patient on GLP 1 analogues and pramlintides.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to compare the effects of Tablet Acotiamide on Gastric emptying time in patients with diabetic gastroparesis	4week drug duration

Secondary Outcome Measures

Name	Time	Method
Gatric antral volume bu USG of gastric antrum and gall bladder ejection fraction will be calculated

Trial Locations

Locations (1)

PGIMER CHANDIGARH; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER CHANDIGARH

🇮🇳Chandigarh, CHANDIGARH, India

DRUSHA DUTTA

Principal investigator

01722756610

ushadutta@gmail.com