Study on the Effect of Domperidone on Blood Sugar Control in Type 1 Diabetes Patients with Delayed Stomach Emptying

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What is this study about?

This clinical trial is focused on studying the effects of a medication called domperidone on people with Type 1 Diabetes who experience delayed stomach emptying but do not have noticeable digestive symptoms. Domperidone is a type of medicine known as a prokinetic agent, which means it helps the stomach move food into the intestines more effectively. The study will compare the effects of domperidone with a placebo to see how well it helps control blood sugar levels in these patients.

The purpose of the study is to evaluate how the treatment affects blood sugar control, which will be monitored using a method called Continuous Glucose Monitoring (CGM). Participants will take either domperidone or a placebo for a certain period, and their blood sugar levels will be tracked to see how much time they spend within a healthy range. The study will also look at other factors like the number of low blood sugar episodes and changes in insulin doses.

Throughout the study, participants will be asked to take the medication or placebo and return any unused capsules. The trial will gather information on various health aspects, including age, sex, and diabetes-related complications, to better understand the effects of the treatment. The study aims to provide insights into how domperidone can help manage blood sugar levels in people with Type 1 Diabetes and delayed stomach emptying.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, type 1 diabetes diagnosis, and current treatment regimen.

Informed consent is required, ensuring understanding of the study’s purpose and procedures.

2 initial assessment

An initial assessment is conducted to gather baseline data, including glycemic control and gastric emptying status.

Continuous glucose monitoring (CGM) devices are used to record blood sugar levels.

3 treatment phase

Participants receive either domperidone or a placebo. Domperidone is administered as a 10 mg film-coated tablet taken orally.

The treatment duration is 14 days, during which the medication is taken as prescribed.

4 monitoring and data collection

Throughout the treatment phase, blood sugar levels are continuously monitored using CGM.

Participants are required to return any unused medication to calculate adherence.

5 final assessment

At the end of the treatment phase, a final assessment is conducted to evaluate changes in glycemic control and gastric emptying.

Data collected includes the percentage of time spent within the target blood sugar range, as well as any hypoglycemic or hyperglycemic episodes.

6 completion of study

Upon completion of the study, participants receive a summary of their individual results.

The study’s findings contribute to understanding the efficacy of domperidone in managing blood sugar levels in type 1 diabetic patients with delayed gastric emptying.

Who Can Join the Study?

Must be a male or female aged 18 years or older, but younger than 75 years.
Must have been diagnosed with Type 1 Diabetes for more than 5 years and be treated with either multiple insulin injections or an insulin pump. Additionally, must use a device that continuously monitors blood sugar levels, known as Continuous Glucose Monitoring (CGM).
Must have a blood sugar target range (70-180 mg/dL) that is less than 60% of the time, or a Coefficient of Variation (CV) greater than 40%, or experience low blood sugar shortly after eating.
Must have few symptoms of gastroparesis (a condition where the stomach takes too long to empty its contents) with a Gastroparesis Cardinal Symptom Index (GCSI) score of 2 or less.
Must have read and understood the information provided about the study and signed a consent form agreeing to participate.
Must be affiliated with a social security scheme.
If a woman is of childbearing potential, she must use effective birth control for at least one month and have a negative pregnancy test at the start of the study. Effective birth control methods include certain hormonal pills, condoms, or other barrier methods with spermicide.
Women who are surgically sterile, meaning they have had procedures like hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, can participate.
Postmenopausal women, defined as not having menstrual periods for 12 months without any other medical reason, can participate. A high level of a hormone called Follicle-Stimulating Hormone (FSH) can confirm this state if not using hormonal treatments.

Who Cannot Join the Study?

Patients who do not have Type 1 Diabetes cannot participate. Type 1 Diabetes is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
Patients who do not have delayed gastric emptying cannot participate. Delayed gastric emptying means that the stomach takes longer than normal to empty its contents into the small intestine.
Patients who have digestive symptoms cannot participate. Digestive symptoms may include nausea, vomiting, or stomach pain.
Patients who have sufficient glycemic control cannot participate. Glycemic control refers to how well a person’s blood sugar levels are managed.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
Patients who are not part of the specified clinical trial group cannot participate. The specific group is not detailed in the provided data.
Patients who are not male or female cannot participate. The study includes both male and female participants.
Patients who are not part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those with certain health conditions.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Groupe Hospitalier du Havre – Hôpital Jacques Monod	Montivilliers	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier de Dieppe	Dieppe	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cwbtxr Huvufjaodxy Iuvbgzrfuvoilx Elpdiql Lgwvhxckp Vqo dg Rrfbl	Saint Aubin Les Elbeuf	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.09.2024

Trial locations

Investigated drugs:

Domperidone

Domperidone is a medication used in this trial to help improve the movement of food through the stomach. It is known as a prokinetic agent, which means it helps the stomach empty its contents more effectively. In this study, it is being tested to see if it can help people with type 1 diabetes who have delayed gastric emptying, which means their stomachs take longer to empty food into the intestines. The goal is to see if using domperidone can improve blood sugar control in these patients.

Investigated diseases:

Type 1 diabetes mellitus

Type 1 Diabetes – Type 1 Diabetes is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It typically appears in adolescence or early adulthood, but it can develop at any age. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas. This leads to high blood sugar levels, which can cause symptoms like increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed properly, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. Management involves monitoring blood sugar levels, insulin therapy, diet, and lifestyle changes.

Gastroparesis – Gastroparesis is a condition that affects the normal spontaneous movement of the muscles in the stomach, causing delayed gastric emptying. It can occur as a complication of diabetes, where high blood sugar levels damage the vagus nerve, which controls the stomach muscles. Symptoms may include nausea, vomiting, feeling full quickly when eating, bloating, and abdominal pain. The progression of gastroparesis can lead to difficulties in managing blood sugar levels due to unpredictable digestion times. This condition can also cause malnutrition and weight loss if not addressed. It requires careful dietary management and sometimes medication to help stimulate stomach muscle contractions.

Trial ID:

2024-514838-20-00

Protocol code:

2021/0380/HP

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Domperidone on Blood Sugar Control in Type 1 Diabetes Patients with Delayed Stomach Emptying

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