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CompletedNCT05789251HGPO-DUNUpdated Aug 6, 2026

Assess the Possibility of Diagnosing Diabetes and Rediabetes Following Oral Induced Hyperglycemia in Patients With Dunnigan's Partial Familial Lipodystrophy by Replacing 75 g of Glucose With a Standardized Carbohydrate Breakfast and Continuous Interstitial Monitoring Glucose)

An interventional study of Standardized breakfast in Lipodystrophy, sponsored by Centre Hospitalier Universitaire de la Réunion. Completed at 1 site in Reunion. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Dunnigan's 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 p.(Thr655Asnfs*49) 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 Dunnigan's 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 Dunningan's 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 Dunnigan's 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 Dunnigan's 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.
02

Conditions studied

  • Lipodystrophy

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03

In context

Lipodystrophy

139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.

This study's enrollment of 54 is above the median of 46 across 97 interventional studies indexed under Lipodystrophy.

Browse Lipodystrophy studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject with Dunnigan's partial familial lipodystrophy followed at Reunion University Hospital not known to be diabetic.

Aged 18 to 75 Having given their .

Exclusion criteria

Exclusion Criteria:

  • Diabetic patient Patient scheduled for scan within 7 days of freestyle placement protected persons: "pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, minor, and person subject to a measure of legal protection: guardianship or curatorship)"
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Standardized breakfast to replace in fine oral induced hyperglycemia test

    Standardized breakfast to replace in fine oral induced hyperglycemia test

    Diagnostic Test: Standardized breakfast

Interventions

  • Diagnostic testStandardized breakfast

    Standardized breakfast to replace in fine oral induced hyperglycemia test

06

What researchers measure

Primary outcomes

  1. standardized breakfast test resuslt compare to oral induced hyperglycemia test

    To assess the concordance between the standard breakfast-induced hyperglycemia test and the classic oral induced hyperglycemia test (gold standard) on the diagnosis of glycemic abnormalities at 120 minutes (min) in patients with Dunnigan's Lipodystrophy in Reunion. It is considered good if \> 80%

    Time frame: 2 hours after standardized breakfast

07

Study locations

1 site
  • Centre Hospitalier Universitaire de La Réunion
    Saint-Denis, 97400, Reunion
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05789251
Responsible party
Sponsor
First posted
Mar 29, 2023
Start date
Jun 19, 2023
Primary completion
Jan 1, 2026
Completion
Jan 28, 2026
Last update
Aug 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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