Search for a Link Between the Different Variables for Glycaemia and Oxidative Stress or Impaired HDL Function

Influence of Glycaemic Variability on Oxidative Stress and High-density Lipoprotein (HDL) Function in Type-1 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02862860

Acronym

Holter Gly

Enrollment

Registered

2016-08-11

Start date

2012-05-29

Completion date

2018-04-17

Last updated

2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type-1 Diabetes

Brief summary

As glycaemic variability on the one hand and hypoglycaemia on the other are associated with oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic properties. The aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions) associated with proatherogenic alterations in lipoproteins, in particular: * LDL oxidation * HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant capacity)

Interventions

BIOLOGICALblood sample

BIOLOGICALurine sample

DEVICEinstallation of Holter

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patients who have provided written consent * Patients with national health insurance cover Patients with T1D * T1D Patients treated with insulin via a pump or multiple injections * HbA1c \< 9.5 % Control patients * Normal fasting glycaemia (\< 6.1 mmol/L) * Age \> 18 years, matched for sex and age with T1D patients All patients * Normal serum HDL cholesterol (\> 1.04 mmol/L in men, \> 1.30 mmol:L in women) * Serum LDL cholesterol \< 5 mmol/L * triglyceridemia \< 1.7 mmol/L * Waist circumference \< 102 cm in men, \< 88 cm in women

Exclusion criteria

* Smoking * Kidney failure (Creatinine clearance\< 60 ml/min/1.73 m2) * Liver failure * Dysthyroidism * Medication that interferes with lipoprotein metabolism (lipid-lowering agents, oestroprogestative, anti-HIV, corticoids, retinoic acid), unless stopped for at least one 1 month * Antioxidant (vitamin E, dietary supplements, DHA) * Pregnancy of more than 15d

Design outcomes

Primary

Measure	Time frame
Average blood glucose	through study completion, an average of 7 days
Time hypoglycemia	through study completion, an average of 7 days
Time hyperglycemia	through study completion, an average of 7 days
Amplitude of glycemic variations	through study completion, an average of 7 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026