Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789251
Status:
RECRUITING
Last Update Posted:
2023-07-10
First Post:
2023-03-16
Brief Title:
Assess the Possibility of Diagnosing Diabetes and Rediabetes Following Oral Induced Hyperglycemia in Patients With Dunnigans Partial Familial Lipodystrophy by Replacing 75 g of Glucose With a Standardized Carbohydrate Breakfast and Continuous Interstitial Monitoring Glucose
Sponsor:
Centre Hospitalier Universitaire de la Réunion
Organization:
Centre Hospitalier Universitaire de la Réunion
Study Overview
Official Title:
Assess the Possibility of Diagnosing Diabetes and Rediabetes Following Oral Induced Hyperglycemia in Patients With Dunnigans Partial Familial Lipodystrophy by Replacing 75 g of Glucose With a Standardized Carbohydrate Breakfast and Continuous Interstitial Monitoring Glucose
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HGPO-DUN
Brief Summary:
Dunnigans syndrome is a partial familial lipodystrophy due to a mutation in the Lamine A LMNA gene This very rare syndrome is 20 times more common in Réunion compared to the rest of Europe with several families suffering from a unique variant of LMNA the pThr655Asnfs49 variant known as the Reunion variant the appearance of which in Reunion dates back to the 17th century This variant is expressed in homozygous and heterozygous form and has only been identified in subjects from Reunion Clinically patients with Dunnigans have an absence of subcutaneous fatty tissue which mainly affects the lower part of the body and leads to severe insulin resistance responsible for early diabetes To detect these metabolic complications as early as possible an annual follow-up of the subjects is recommended with the performance of an OGTT test annually in non-diabetic subjects This problem is identical for patients with cystic fibrosis leading to the same recommendation However whether in our experience of monitoring patients with Dunningans lipodystrophy in subjects at risk of diabetes or in subjects with cystic fibrosis the OGTT test and even more so its repetition is poorly accepted which can lead to lack of patient follow-up An alternative solution to the OGTT is therefore justified
In the literature different avenues have been explored First given oral glucose intolerance replacement with a standardized breakfast has been explored in several studies Another alternative tested in the population of subjects with cystic fibrosis is the use of an interstitial glucose sensor for screening for carbohydrate abnormalities
In view of the literature we formulate several hypotheses that will be tested in our study
1 The intake of a standardized breakfast containing 75g of carbohydrates is comparable to the ingestion of 75g of glucose on the result of the OGTT test at 120 min for the diagnosis of carbohydrate abnormalities diabetes and prediabetes in patients with Dunnigans lipodystrophy
2 The continuous recording of interstitial glycaemia over several days allows the diagnosis of glucidic abnormalities equivalent to the classic OGTT in this population possibly by identifying glycemic variations not seen by a single OGTT test Thus the installation of an interstitial sensor over several days could be an alternative to the realization of the OGTT in the identification of carbohydrate disorders in patients with Dunnigans lipodystrophy
3 There will be a similar profile but a time lag between venous glycemic curves and interstitial blood glucose measurements after OGTT
4 Replacing the oral glucose load of the classic OGTT gold standard with a standardized carbohydrate breakfast leads to similar interstitial glycaemia curves but with a time lag
In the literature different avenues have been explored First given oral glucose intolerance replacement with a standardized breakfast has been explored in several studies Another alternative tested in the population of subjects with cystic fibrosis is the use of an interstitial glucose sensor for screening for carbohydrate abnormalities
In view of the literature we formulate several hypotheses that will be tested in our study
1 The intake of a standardized breakfast containing 75g of carbohydrates is comparable to the ingestion of 75g of glucose on the result of the OGTT test at 120 min for the diagnosis of carbohydrate abnormalities diabetes and prediabetes in patients with Dunnigans lipodystrophy
2 The continuous recording of interstitial glycaemia over several days allows the diagnosis of glucidic abnormalities equivalent to the classic OGTT in this population possibly by identifying glycemic variations not seen by a single OGTT test Thus the installation of an interstitial sensor over several days could be an alternative to the realization of the OGTT in the identification of carbohydrate disorders in patients with Dunnigans lipodystrophy
3 There will be a similar profile but a time lag between venous glycemic curves and interstitial blood glucose measurements after OGTT
4 Replacing the oral glucose load of the classic OGTT gold standard with a standardized carbohydrate breakfast leads to similar interstitial glycaemia curves but with a time lag
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None