Diabetic Gastroparesis Research Study
Gastroparesis is a disorder characterised by signs and symptoms of:
- Abdominal pain
- Postprandial fullness
- Early satiety along with delayed gastric emptying
The movement of food from the stomach to the small intestine takes longer than normal and occurs with unpredictable timing.
Diabetes Mellitus, either Type 1 or 2 is considered to be the most common identifiable cause of Gastroparesis. This complication is a result of chronically elevated blood glucose levels, which are known to damage nerve structure and function. Diabetic Gastroparesis complicates the management of blood glucose for Type 1 and Type 2 diabetic patients due to carbohydrates being delivered to and therefore absorbed from the small intestine at variable times after ingestion.
Over time diabetes can affect many parts of your body. One of those can be the Vagus nerve which controls how quickly your stomach empties. When the Vagus nerve is damaged, your digestion slows and food stays in your body longer than it should.
There is a significant need for a safe and effective treatment for patients with Diabetic Gastroparesis whose quality of life is impacted by their disease and for whom the current standard of care is of optimum quality.
Male and Female
SAHPRA approval date 22 February 2019 (Ref No: 20181013/20181014/20181015)
Pharma Ethics approval RLM-MD-02 dated 27 November 2018 (Ref No: 181021594)
Pharma Ethics approval RLM-MD-03 dated 28 November 2018 (Ref No: 181021602)
Pharma Ethics approval RLM-MD-04 dated 29 November 2018 (Ref No: 181021612)
HREC approvals dated 21 December 2018 (Ref No: 181001/181002/181003)
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