Diabetic Gastroparesis

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Diabetic Gastroparesis

General Purpose:

Gastroparesis is a condition that arises when the vagus nerve becomes damaged. The vagus nerve controls the muscles of the stomach. When it is damaged, the movement of food from the stomach into the intestines slows significantly and can even stop altogether.

Although most cases of gastroparesis occur for no identifiable reason, the most common known cause of gastroparesis is diabetes, as excess levels of blood glucose can damage the vagus nerve over time. Symptoms of gastroparesis include nausea, vomiting, gastroesophageal reflux (also known as acid reflux), stomach pain, abdominal bloating, and decreased appetite.

Unfortunately, gastroparesis is usually a chronic condition and symptoms may come and go over time. There is no cure for gastroparesis, however treatments can help manage symptoms and make those affected by the condition more comfortable.

Effective treatments often include dietary modifications, certain medications, mild electrical stimulation of the stomach muscles, and use of a feeding tube (in severe cases). Additionally, treatment of gastroparesis for individuals with diabetes relies heavily on effective blood sugar control. Researchers are currently focused on developing more effective methods of treating diabetic gastroparesis and minimizing its symptoms.

What Will A Diabetic Gastroparesis Clinical Trial Be Like?

The types of tests and assessments used in diabetic gastroparesis clinical trials will ultimately depend on the specific nature of the study and what aspects of diabetic gastroparesis are being investigated. Provided below is a list of frequent procedures and tests that may be incorporated for use in clinical trials:

  • Physical exam
  • Glycated hemoglobin test (A1C test): a blood test that indicates an individual’s average blood sugar level over the prior two months.
  • Random, standard blood sugar tests that measure the amount of glucose in the blood at a particular point in time.
  • Fasting blood sugar tests that measure blood sugar levels following an overnight fast.
  • Oral glucose tolerance tests: this test involves overnight fasting, followed by a fasting blood sugar test, then consumption of a sugary liquid. Blood sugar levels are then tested periodically over the following few hours.
  • Nerve conduction tests to monitor the health of specific nerves that control the stomach and intestines.
  • Upper gastrointestinal (GI) endoscopy: a procedure during which a thin, flexible tube with a tiny light and camera attached to the end is fed down the mouth or nose, through the esophagus, and into the stomach and first part of the small intestine.
  • Upper GI series: a series of x-rays performed after an individual has fasted for a period of time and then consumed a chalky-tasting liquid that makes the stomach and intestines more visible on x-ray.
  • Ultrasound
  • Gastric emptying scintigraphy: a test that involves an individual eating a bland meal that contains a tiny amount of radioactive material. This radioactive material can then be observed using a special external scanner as it passes through the stomach and intestines. A similar test, known as a breath test, involves an individual eating a similar meal and then providing breath samples over a period of several hours. The samples are analyzed to determine the amount of radioactive material in the person’s breath.
  • SmartPill: a small electronic device in the form of a capsule, much like a medication, that takes pictures of areas inside the body. It is swallowed and then excreted.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as food and/or exercise diaries, may also be required in some studies, depending on the research question being studied.

Typical Diabetic Gastroparesis Clinical Trial Protocol:

Specific examples of clinical trials for diabetic gastroparesis might include the following:

  • A randomized study in which individuals with diabetic gastroparesis are randomly assigned to receive either acupuncture or a placebo/mock acupuncture treatment. The purpose of such a study would be to determine if acupuncture is an effective alternative therapy for diabetic gastroparesis.
  • A randomized clinical trial in which three groups of subjects with diabetic gastroparesis are randomly assigned to receive treatment with one or two dosages of an investigational medication, or a placebo. The purpose of such a study would be to determine the safety and effectiveness of the investigational drug as a treatment for gastroparesis among diabetic individuals.
  • A randomized clinical trial to determine if a supplemental form of the hormone oxytocin can increase the speed of gastric emptying (i.e., moving food out of the stomach) among diabetic patients with gastroparesis and severe vagal nerve damage.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or treatment is being evaluated for the first time (such as the first and second examples provided above), the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed: 

The type of clinical trial you may be eligible for often depends on many factors, including your history of diabetes, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your most recent A1C measurement
  • Your family history of diabetes
  • Your history of diabetic gastroparesis
  • Your prior history of treatment for diabetes and other medical conditions (including any surgeries, procedures, and medications)
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels (if known)

Suggested Search Terms: 

Once you are ready to begin your search for clinical trials, the following key words may be of use when combined with the phrase “diabetic gastroparesis”: “pediatric,” “treatment,” “medication,” “surgery,” “prevention,” “diet,” “exercise,” “nutrition,” “complications,” and “management.”

Current Search Term:

“Diabetic Gastroparesis”

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Gastric Per Oral Endoscopic Myotomy (G-POEM) in Refractory Gastroparesis


Conditions:   Gastroparesis Postoperative;   Gastroparesis Due to Diabetes Mellitus;   Idiopathic Gastric Stasis
Intervention:   Procedure: G-POEM
Sponsor:   Coordinación de Investigación en Salud, Mexico
Recruiting - verified April 2017


Per-oral Endoscopy Pyloromyotomy (G-POEM) in the Treatment of Refractory Diabetic Gastroparesis : Prospective Evaluation of Efficacy


Condition:   Gastroparesis
Interventions:   Procedure: Per-oral endoscopy pyloromyotomy;   Procedure: Intrapyloric injection of Botulinum toxin
Sponsor:   Assistance Publique Hopitaux De Marseille
Not yet recruiting - verified October 2016


G-POEM for Treatment of Refractory Gastroparesis


Conditions:   Diabetic Gastroparesis;   Idiopathic Gastroparesis;   Gastroparesis Postoperative
Intervention:   Procedure: Gastric POEM
Sponsor:   Johns Hopkins University
Recruiting - verified March 2017


A Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis


Conditions:   Diabetes Mellitus;   Diabetes Mellitus Complications;   Gastroparesis
Interventions:   Drug: RM-131;   Drug: Placebo
Sponsor:   Motus Therapeutics, Inc.
Completed - verified September 2016


Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)


Condition:   Diabetic Gastroparesis
Interventions:   Drug: IW-9179;   Drug: Matching Placebo
Sponsor:   Ironwood Pharmaceuticals, Inc.
Completed - verified January 2016


Study of Promethazine for Treatment of Diabetic Gastroparesis


Condition:   Diabetic Gastroparesis
Interventions:   Drug: Promethazine;   Drug: Sugar pill
Sponsors:   Dartmouth-Hitchcock Medical Center;   American College of Gastroenterology
Recruiting - verified May 2017


Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis


Condition:   Diabetic Gastroparesis
Interventions:   Drug: Metoclopramide Nasal Spray;   Drug: Placebo Nasal Spray
Sponsor:   Evoke Pharma
Completed - verified August 2016


Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis


Condition:   Diabetic Gastroparesis
Interventions:   Drug: Metoclopramide Nasal Spray;   Drug: Placebo Nasal Spray
Sponsor:   Evoke Pharma
Completed - verified February 2017


Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients


Conditions:   Idiopathic Gastroparesis;   Diabetic Gastroparesis
Interventions:   Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA);   Device: 19 guage fine needle aspiration needle
Sponsor:   Texas Tech University Health Sciences Center, El Paso
Completed - verified July 2016


Gastroparesis Registry 2


Conditions:   Gastroparesis;   Diabetic Gastroparesis;   Idiopathic Gastroparesis
Intervention:  
Sponsor:   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruiting - verified October 2016


Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis


Conditions:   Diabetes Mellitus;   Diabetes Mellitus Complications;   Gastroparesis
Interventions:   Drug: RM-131;   Drug: Placebo
Sponsor:   Motus Therapeutics, Inc.
Completed - verified September 2016


Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis


Condition:   Diabetic Gastroparesis
Interventions:   Dietary Supplement: dietary treatment: food of small particle size;   Radiation: Validate X-ray diagnostic method.;   Other: Can the motility be improved;   Biological: postprandial plasma glucose
Sponsor:   Göteborg University
Recruiting - verified February 2017


Transcutaneous Electroacupuncture for Gastroparesis


Condition:   Diabetic Gastroparesis
Interventions:   Device: TEA;   Device: Sham-TEA
Sponsors:   Transtimulation Research, Inc;   National Center for Complementary and Integrative Health (NCCIH);   University of Mississippi Medical Center;   Texas Tech University Health Sciences Center
Completed - verified April 2017


Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis


Conditions:   Diabetes Mellitus Type 1 and 2;   Diabetes Mellitus Complications;   Gastroparesis;   Gastrointestinal Motility Disorder
Interventions:   Drug: RM-131;   Drug: Placebo
Sponsor:   Motus Therapeutics, Inc.
Completed - verified September 2016


Impact of KUVAN® on Gastric Relaxation in Women With Diabetic Gastroparesis.


Condition:   Gastroparesis
Intervention:   Drug: sapropterin dihydrochloride
Sponsor:   Stanford University
Completed - verified February 2017

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