INSUlin Regimens and VASCular Functions

Type 2 Diabetes Clinical Trial

— INSUVASC  

Official title:

Effects of Different Insulin Regimens on Artery Compliance, Endothelium Function and Autonomic Cardiac Function in Patients With Poorly Controlled Type 2 Diabetes: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022658
• Other study ID #: P090303
• Status: Completed
• Phase: N/A
• First received: November 30, 2009
• Last updated: February 20, 2013
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: February 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The aim of this pilot study is, in type 2 diabetic patients now requiring insulin, to compare the effects of improving glycemic control on these parameters with 3 different insulin regimens which will act especially at fasting or in post-prandial periods or both. Non invasive explorations will be performed before randomization and after 4 to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.

Description:

Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The effect of controlling fasting or post-prandial blood glucose or both on these parameters has not been studied in type 2 diabetic patients.

The aim of this pilot study is to compare the effects of improving fasting or post-prandial blood glucose glycemic control or both with 3 different insulin regimens for 4 to 5 weeks, on vago-sympathetic activity, arterial stiffness and endothelial function.

Patients will be recruited in the department of Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, and the department of Endocrinology and Metabolism of AVICENNE hospital, BOBIGNY, AP-HP, France. After an half day of cardiovascular explorations, 42 patients will be randomized in 3 groups determining their treatment for the following 4-5 weeks : insulin therapy with detemir at dinner or bed time, or with aspart at each meal, or with both of them.

Investigations will be performed in the morning 1) at the time of randomisation and 2) 4-5 weeks after the beginning of insulin therapy. We will evaluate at fasting and each hour after a standardized breakfast biological and metabolic parameters, arterial stiffness, endothelial function and nervous autonomic system with non-invasive devices: Sphygmocor®, Finapres®, laser-doppler et Endopat2000®. Body composition will be evaluated with impedance maestri and BodPod®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 72 Years

Eligibility

Inclusion Criteria:

• Consent patient

• Adults from 30 to 72 years old

• type 2 diabetic patients for at least 1 year

• able to self measure capillary blood glucose

• body mass index 20-37 kg/m²,

• HbA1c 7.1-12% under Metformin and SULFUNYREAS therapy for at least 2 months

• anti-hypertensive treatment or dyslipidemic treatment unchanged for 3 months

Exclusion criteria:

• pregnancy

• other antidiabetic medication in the previous 2 months,

• anti-hypertensive or lipid-lowering therapies having been changed in the previous 2 months,

• insulin allergy,

• uncontrolled preproliferative or proliferative diabetic retinopathy

• uncontrolled hypertension

• renal failure(creatinin clearance <40 ml/min)

• hepatocellular deficiency (prothrombin time <70%)

• anemia

• peripheral occlusive arterial disease

• cardiac arrhythmia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Insulin
For diabetes treatment: metformin continued with insulin (according to arms)

Locations

Country	Name	City	State
France	Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition	Bondy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (11)

Albertini JP, Valensi P, Lormeau B, Aurousseau MH, Ferrière F, Attali JR, Gattegno L. Elevated concentrations of soluble E-selectin and vascular cell adhesion molecule-1 in NIDDM. Effect of intensive insulin treatment. Diabetes Care. 1998 Jun;21(6):1008-13. — View Citation

Ceriello A, Taboga C, Tonutti L, Quagliaro L, Piconi L, Bais B, Da Ros R, Motz E. Evidence for an independent and cumulative effect of postprandial hypertriglyceridemia and hyperglycemia on endothelial dysfunction and oxidative stress generation: effects of short- and long-term simvastatin treatment. Circulation. 2002 Sep 3;106(10):1211-8. — View Citation

Dabiré H, Brahimi M, Hadj-Brahim F, Le Clésiau H, Attali JR, Valensi P. [Role of vagosympathetic balance in obesity-induced hypertension]. Arch Mal Coeur Vaiss. 2004 Jul-Aug;97(7-8):749-52. French. — View Citation

Nitenberg A, Cosson E, Pham I. Postprandial endothelial dysfunction: role of glucose, lipids and insulin. Diabetes Metab. 2006 Sep;32 Spec No2:2S28-33. Review. — View Citation

Sibony-Prat J, Paries J, Chabert M, Attali JR, Valensi P. [Alteration of cardiovascular vagosympathetic control evaluated by spectral analysis of variations of heart rate and blood pressure in obesity]. Arch Mal Coeur Vaiss. 1997 Aug;90(8):1155-8. French. — View Citation

Valensi P, Cosson E. Hemodynamic changes in postprandial state. Diabetes Metab. 2006 Sep;32 Spec No2:2S37-41. Review. — View Citation

Valensi P, Pariès J, Attali JR; French Group for Research and Study of Diabetic Neuropathy. Cardiac autonomic neuropathy in diabetic patients: influence of diabetes duration, obesity, and microangiopathic complications--the French multicenter study. Metabolism. 2003 Jul;52(7):815-20. — View Citation

Valensi P, Pariès J, Lormeau B, Attia S, Attali JR. Influence of nutrients on cardiac autonomic function in nondiabetic overweight subjects. Metabolism. 2005 Oct;54(10):1290-6. — View Citation

Valensi P, Smagghue O, Pariès J, Velayoudon P, Lormeau B, Attali JR. Impairment of skin vasoconstrictive response to sympathetic activation in obese patients: influence of rheological disorders. Metabolism. 2000 May;49(5):600-6. — View Citation

Valensi P, Smagghue O, Pariès J, Velayoudon P, Nguyen TN, Attali JR. Peripheral vasoconstrictor responses to sympathetic activation in diabetic patients: relationship with rheological disorders. Metabolism. 1997 Mar;46(3):235-41. — View Citation

Valensi P, Thi BN, Lormeau B, Pariès J, Attali JR. Cardiac autonomic function in obese patients. Int J Obes Relat Metab Disord. 1995 Feb;19(2):113-8. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vago-sympathetic activity, arterial stiffness, endothelial function		4-5 Weeks	Yes