NCT02528695

Brief Summary

The metabolic function of different white adipose tissue depots in the body and its role in the development of type 2 diabetes (T2D) remains unclear. Several studies have used fluor-18 fluorodeoxyglucose positron emission tomography with computed tomography (FDG PET/CT) to image the metabolic activity of different adipose tissues in lean and obese healthy subjects and in patients with T2D with or without euglycaemic hyperinsulinemic clamping, describing differences in metabolic activity of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) and gluteal-femoral adipose tissue (GFAT). Recently, FDG PET/CT showed high glucose uptake in VAT and SAT under unintentional hypoglycaemic conditions in a non-diabetic patient. Evaluation of potential differences in FDG uptake in white adipose tissue between healthy volunteers and T2D patients and between VAT, SAT and GFAT in these subjects under hyperinsulinemic hypoglycaemic conditions would be of great value in further exploring the pathogenesis of insulin resistance in T2D.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable diabetes-mellitus-type-2

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

Study Start

First participant enrolled

November 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 31, 2017

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

August 18, 2015

Last Update Submit

May 29, 2017

Conditions

Diabetes Mellitus Type 2

Keywords

18F-FDG PET/CTAdipose tissuetype 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Glucose uptake in adipose tissue measured by uptake of 18F-FDG on PET images

    1 year

Study Arms (3)

Healthy euglycemic clamp

ACTIVE COMPARATOR

In 5 healthy volunteers an 18F-FDG PET/CT will be performed during an euglycemic clamp

Radiation: 18F-FDG PET/CTDevice: euglycemic clamp

healthy hypoglycemic clamp

ACTIVE COMPARATOR

In 5 healthy volunteers an 18F-FDG PET/CT will be performed during a hypoglycemic clamp

Radiation: 18F-FDG PET/CTDevice: hypoglycemic clamp

Type 2 diabetes hypoglycemic clamp

EXPERIMENTAL

In 5 type 2 diabetes patients, an 18F-FDG PET/CT will be performed during a hypoglycemic clamp

Radiation: 18F-FDG PET/CTDevice: hypoglycemic clamp

Interventions

18F-FDG PET/CTRADIATION

18F-FDG PET/CT

Healthy euglycemic clampType 2 diabetes hypoglycemic clamphealthy hypoglycemic clamp
euglycemic clampDEVICE

euglycemic clamp

Healthy euglycemic clamp
hypoglycemic clampDEVICE

hypoglycemic clamp

Type 2 diabetes hypoglycemic clamphealthy hypoglycemic clamp

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years
  • BMI 27-40
  • For healthy volunteers:
  • Fasting blood glucose \< 6.1 mmol/L
  • HbA1c \< 42 mmol/mol (6%)
  • For T2D patients:
  • Clinical overt Type 2 Diabetes
  • on a glucose-lowering diet or on oral glucose-lowering medication
  • T2D stable and under control for minimal 2 years
  • HbA1c \< 75 mmol/mol (9%)

You may not qualify if:

  • Renal dysfunction
  • Overt symptomatic neuropathy or proliferative retinopathy
  • A history of cardiovascular disease complications (myocardial infarction, stroke, peripheral artery disease)
  • Pregnancy or lactating
  • Using subcutaneous insulin
  • Incapability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RadboudUMC

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucose Clamp Technique

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Martin Gotthardt, Prof. Dr.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 19, 2015

Study Start

November 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 31, 2017

Record last verified: 2016-04

Locations

NL(1)