NCT01022658

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

1.5 years

First QC Date

November 30, 2009

Last Update Submit

February 20, 2013

Conditions

Type 2 Diabetes

Keywords

Insulin TherapyVago-sympathetic activityarterial stiffnessendothelial function

Outcome Measures

Primary Outcomes (1)

  • Vago-sympathetic activity, arterial stiffness, endothelial function

    4-5 Weeks

Study Arms (3)

detemir

ACTIVE COMPARATOR

Insulin detemir at dinner or bedtime

Drug: Insulin

aspart

ACTIVE COMPARATOR

Insulin aspart before each meal

Drug: Insulin

detemir and aspart

ACTIVE COMPARATOR
Drug: Insulin

Interventions

InsulinDRUG

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

Also known as: LEVEMIR, NOVORAPID
aspartdetemirdetemir and aspart

Eligibility Criteria

Age30 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition

Bondy, 93140, France

Location

Related Publications (12)

  • Nitenberg A, Cosson E, Pham I. Postprandial endothelial dysfunction: role of glucose, lipids and insulin. Diabetes Metab. 2006 Sep;32 Spec No2:2S28-33. doi: 10.1016/s1262-3636(06)70482-7.

    PMID: 17375404BACKGROUND

  • Albertini JP, Valensi P, Lormeau B, Aurousseau MH, Ferriere 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. doi: 10.2337/diacare.21.6.1008.

    PMID: 9614623BACKGROUND

  • Valensi P, Cosson E. Hemodynamic changes in postprandial state. Diabetes Metab. 2006 Sep;32 Spec No2:2S37-41. doi: 10.1016/s1262-3636(06)70484-0.

    PMID: 17375406BACKGROUND

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

    PMID: 7735337BACKGROUND

  • Dabire H, Brahimi M, Hadj-Brahim F, Le Clesiau 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.

    PMID: 15506059BACKGROUND

  • Valensi P, Paries 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. doi: 10.1016/s0026-0495(03)00095-7.

    PMID: 12870154BACKGROUND

  • Valensi P, Paries 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. doi: 10.1016/j.metabol.2005.04.016.

    PMID: 16154426BACKGROUND

  • 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. doi: 10.1161/01.cir.0000027569.76671.a8.

    PMID: 12208795BACKGROUND

  • Valensi P, Smagghue O, Paries 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. doi: 10.1016/s0026-0495(97)90246-8.

    PMID: 9054462BACKGROUND

  • Valensi P, Smagghue O, Paries 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. doi: 10.1016/s0026-0495(00)80034-7.

    PMID: 10831169BACKGROUND

  • 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.

    PMID: 9404427BACKGROUND

  • Fysekidis M, Cosson E, Takbou K, Sutton A, Charnaux N, Banu I, Vicaut E, Valensi P. Effects of insulin analogs as an add-on to metformin on cutaneous microcirculation in type 2 diabetic patients. Microvasc Res. 2018 Mar;116:6-14. doi: 10.1016/j.mvr.2017.09.005. Epub 2017 Sep 24.

    PMID: 28954218DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

InsulinInsulin DetemirInsulin Aspart

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-ActingInsulin, Short-Acting

Study Officials

  • Paul Valensi, Pr

    CHU Jean VERDIER

    PRINCIPAL INVESTIGATOR

  • Emmanuel Cosson, MD, PhD

    CHU-Jean Verdier

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 1, 2009

Study Start

January 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 21, 2013

Record last verified: 2013-02

Locations

FR(1)