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Patients living with type 1 diabetes (PwT1D) still have trouble controlling their blood sugar, even with the latest treatments. PwT1D may have slow stomach emptying influencing blood glucose level. Treating this is an important goal. A recent study found that 30% of PwT1D had a slower gastric emptying rate, even though they had no other complications and were not experiencing any digestive issues. Slowing of gastric emptying is linked to gastric hypoglycaemia, which is a life-threatening condition that can affect quality of life, and to higher blood sugar level after eating. This can last throughout the night. Prokinetic treatments for the stomach are good for diabetic patients with slow digestion. These treatments help with stomach pain and, to a lesser extent, with hypoglycemia. However, there is no data on the benefits of such treatments in patients with no digestive symptoms, on glycaemic control as defined by continuous glucose monitoring data. In fact, this may be more relevant than HbA1c in patients with alternating hypo- and/or hyperglycaemia.
The investigator thinks that a prokinetic agent like domperidone could improve glycaemic control in PwT1D with slow gastric emptying and glycaemic imbalance.
This study tests how domperidone affects blood sugar levels in PwT1D. Patients will be administrated domperidone or a placebo for 28 days. The investigator will see how long T1D patients spend within their blood sugar target range over 14 days using a continuous glucose monitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Domperidone then placebo | Experimental | Domperidone 10 mg, 3/days during 28 days, - wash-out (21 days) then placebo 3/days during 28 days |
|
| Placebo then Domperidone | Experimental | Placebo 3/days during 28 days - wash-out (21 days) - then Domperidone 10 mg, 3/days during 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domperidone 10mg | Drug | 30 mg per day for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of time spent within the TIR (Time In Range) glycemic target range (70-180 mg/dL) | The difference of percentages of time spent within the TIR glycemic target range (70-180 mg/dL) recorded over 14 days under prokinetic treatment (domperidone) or placebo in T1D patients with gastroparesis and inadequate glycemic control | 14 days after domperidone or placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in glycemic control criteria : HbA1c assay | Variation in HbA1c assay between domperidone and placebo (measurement of differences) | 14 days after domperidone of placebo |
| Variation in glycemic control criteria : Plasma fructosamine assay |
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Inclusion Criteria:
Exclusion Criteria:
Type 2 diabetic patients
Patients with CGM<70%
Type 1 diabetic patients with glycemic target TIR (70-180 mg/dL) < 40%
Patients with renal insufficiency (GFR<60 ml/min according to CKD-EPI formula),
Patients with contraindications to DOMPERIDONE ARROW 10 mg film-coated tablet:
Contraindication to gastric emptying test : - allergy to eggs, gluten, milk proteins, etc. - hepatic insufficiency - pulmonary diffusion disorders
Contraindication to placebo (calcium content): hypercalcemia/hypercalciuria, known calcium lithiasis
Pregnant, parturient or breast-feeding women, or those without proven effective contraception
Person deprived of liberty by an administrative or judicial decision, or person under court protection, subguardianship or guardianship
Person taking part in another trial / having taken part in another therapeutic trial (study involving a drug or medical device) which could interfere with the products or procedures being investigated within a period of 4 weeks prior to inclusion
Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or from giving informed consent
Patients treated with a closed insulin loop
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaetan PREVOST, Pr | Contact | 232889061 | +33 | gaetan.prevost@chu-rouen.fr |
| Armelle Guidotti | Contact | 232888265 | +33 | armelle.guidotti@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | France |
|
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| Placebo | Drug | 3 per day for 21 days |
|
| gastric emptying test | Diagnostic Test | gastric emptying test |
|
Variation in Plasma fructosamine assay between domperidone and placebo (measurement of differences)
| 14 days after domperidone of placebo |
| Variation in glycemic control criteria : Insulin dose | Variation in Insulin dose between domperidone and placebo (measurement of differences) | 14 days after domperidone of placebo |
| Safety Outcome : AE and SAE Occurrence | Number of AE and SAE | 105 days |
| CHU de CAEN | Caen | France |
|
| CH Dieppe | Dieppe | France |
|
| Centre Hospitalier Intercommunal Elbeuf, Louviers, Val de Reuil | Elbeuf | France |
|
| GH Le Havre | Le Havre | France |
|
| CHU de ROUEN | Rouen | France |
|
| ID | Term |
|---|---|
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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