NCT02102737

Brief Summary

Insulin resistance is closely associated with apparition of type 2 diabetes mellitus; it is an independent risk factor and predicts future cardiovascular events. Hyperinsulinemic euglycemic clamp is a validated method to assessment of insulin resistance and It is also the gold standard technique. However, the complexity and length of this technique render it unsuitable for routine clinical use. In this study, the investigators use a new technique to provide precise, objective, fast and automated quantification of insulin resistance with camera SPECT. They compare the results with those of the measurement of hyperinsulinemic euglycemic clamp in population with or without insulin resistance. The proposed study is to validate this new non-invasive imaging technique for evaluation of insulin resistance in patients with or without insulin resistance with a comparison with hyperinsulinemic euglycemic clamp.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus

Timeline
Completed

Started May 2014

Typical duration for phase_2 diabetes-mellitus

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

March 25, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 13, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

3.8 years

First QC Date

March 25, 2014

Last Update Submit

August 25, 2021

Conditions

Diabetes MellitusInsulin ResistanceGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Keywords

insulin resistanceScintigraphyHyperinsulinemic euglycemic clamp

Outcome Measures

Primary Outcomes (1)

  • Correlation between measure of insulin resistance measurement by scintigraphy and hyperinsulinemic euglycemic clamp

    Correlation between measure of insulin resistance measurement by scintigraphy (insulin resistance index: ratio scintigraphy measurement of glucose transport in heart before and after infusion of insulin) and hyperinsulinemic euglycemic clamp (Glucose Infusion Rate and sensibility index Clamp)

    DAY 1 AND DAY 2

Secondary Outcomes (9)

  • SAFETY

    visit 2, visit 3 and visit 4

  • Reproducibility

    day 2 and day 3

  • Left ventricule ejection fraction

    day 2

  • left ventricle volume

    day 2

  • cardiac mass

    day 2

  • +4 more secondary outcomes

Study Arms (1)

6-DIG and clamp

EXPERIMENTAL

injection of 6-DIG and hyperinsulinemic euglycemic clamp

Drug: 6-DIGProcedure: clamp

Interventions

6-DIGDRUG

injection of 6-DIG

6-DIG and clamp
clampPROCEDURE

hyperinsulinemic euglycemic clamp

6-DIG and clamp

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Insulin sensible patients
  • Body mass index \< 25 HOMA \<= 2.5
  • Waist measurement \< 94 cm for men and \< 80 cm for women
  • HDL cholesterol 1,03 mmol/L for men and \> 1,29 mmol/L for women
  • Triglyceride level ≤ 1,69 mmol/ L
  • For women not menopausal since at last one year or not surgically sterilised:
  • On-going contraception, physical or hormonal, excepted local methods (spermicidal, diaphragm, condom, cape)
  • \- Insulin resistant patients
  • For women not menopausal since at last one year or not surgically sterilised:
  • On-going contraception, physical or hormonal, excepted local methods (spermicidal, diaphragm, condom, cape)
  • HOMA \> 2.5
  • Body mass index \> 25
  • Waist measurement \> 94 cm for men and \> 80 cm for women
  • HDL cholesterol \< 1,03 mmol/L et for men and ≤ 1,29 mmol/L for women
  • Triglyceride level \> 1,69 mmol/ L

You may not qualify if:

  • Instable cardiomyopathy
  • Severe hypertension defined by par SAP \> 180 mmHg and/or DAP \> 110 mmHg
  • Psychiatric illness, needing a chronic treatment
  • Previous history of stroke, epilepsy, cranial trauma, pituitary surgery, disease likely to reduce the ability of absorption, diffusion or excretion of the radiotracer.
  • Allergy to one of the components of the products used during the study
  • Treatment likely to interfere with glucose metabolism
  • Alcohol or drug intoxication
  • Vegetarian or restrictive low-calory diet,
  • Pregnant, parturient or breast-feeding women,
  • Inappropriate way of life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Michallon . CHU Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Diabetes MellitusInsulin ResistanceGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Interventions

Constriction

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Gilles Barone-Rochette, PHU

    Hopital Michalon , CHU de Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2014

First Posted

April 3, 2014

Study Start

May 13, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

FR(1)