Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Multi-Tracer Pet Quantitation of Insulin Action

28 juli 2017 uppdaterad av: Bret Goodpaster, University of Pittsburgh

We are proposing a clinical investigation of the pathogenesis of insulin resistance (IR) in skeletal muscle and adipose tissue (AT), focusing specifically on the contributions of glucose delivery, transport and phosphorylation. The primary methodology will be dynamic PET imaging, using three tracers that respectively portray the kinetics of glucose delivery, bi-directional trans-membrane glucose transport and glucose phosphorylation. The three tracers are: 1) [15O]-H2O for quantifying tissue perfusion, this portrays the kinetics of glucose delivery from plasma to tissue; 2) [11C]-3-O-methyl glucose, a tracer constrained to bi-directional trans-membrane glucose transport; and 3) [18F]-fluoro-deoxy glucose, which like [11C]-3-OMG is transported, but adds the subsequent metabolic step, that of glucose phosphorylation.

We propose 2 specific aims to apply this methodology to investigate the pathogenesis of IR. The 1st aim is to quantitatively assess the kinetics of glucose delivery, transport and phosphorylation in skeletal muscle in type 2 DM and as compared to obese and lean non-diabetic men and women. We will appraise the contribution of each step to the to the pathogenesis of IR. We postulate more severe IR in oxidative muscle, with a dual impairment of glucose transport and phosphorylation. The 2nd aim is to implement the triple-tracer dynamic PET imaging protocol in adipose tissue (AT), examining normal insulin action in non-obese volunteers and testing whether differences in AT insulin action are present in obese insulin sensitive volunteers compared to obese IR participants and the relation of AT IR to that of muscle and liver.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

We propose a clinical investigation of the pathogenesis of insulin resistance (IR) in skeletal muscle and adipose tissue (AT) in obesity and diabetes mellitus, focusing on the separate and interactive roles of glucose delivery, bi-directional trans-membrane glucose transport and glucose phosphorylation. The primary methodology will be dynamic PET imaging, using three tracers that respectively portray the kinetics of glucose delivery, transport and phosphorylation. The three tracers are: 1) [15O]-H2O for quantifying tissue perfusion, this parameter together with glucose concentration portrays the kinetics of glucose delivery from plasma to tissue interstitial space; 2) [11C]-3-O-methyl glucose, a tracer constrained to bi-directional trans-membrane glucose transport; and 3) [18F]-fluoro-deoxy glucose, which like [11C]-3-OMG is transported, but adds the subsequent metabolic step, that of glucose phosphorylation.

In our recently completed studies, we implemented this triple-tracer dynamic PET imaging protocol to investigate insulin action in lean, healthy individuals 1-3. Rates of glucose uptake can be obtained by other methods (e.g. the glucose clamp, arterio-venous limb balance). What is uniquely valuable with dynamic PET imaging is acquisition of a temporal plot of tracer uptake, one that is obtained within an organ rather than derived from plasma determinations. These tissue-time activity curves provide information to assess the velocity of metabolic steps. By doing this for each of the three tracers, assessment can be made of which among glucose delivery, transport and phosphorylation is rate-controlling, or more properly, how rate control is distributed amongst these steps. The triple-tracer procedure has provided novel, quantitative insight on the action of insulin to change this distribution of control, a re-distribution triggered in healthy individuals by robust activation of glucose transport. Robust activation of glucose transport increases permeability of muscle to glucose sufficiently that delivery manifests greater rate limitation than during basal conditions. Also, we have coupled PET bio-imaging with MRI to study specific muscles 1, 3. This approach has yielded provocative and unanticipated new findings. Unlike in lean non-diabetics, in whom oxidative muscle is more insulin sensitive (as widely demonstrated in animal studies), in type 2 and in type 1 DM, oxidative muscle is more severely IR. We are encouraged that this bio-imaging methodology will enable new insight into the pathogenesis of IR in skeletal muscle and that the approach can be successfully adapted for in vivo investigation of adipose tissue metabolism.

The 1st specific aim is to quantitatively assess the contribution of glucose delivery, transport and phosphorylation to the pathogenesis of skeletal muscle IR in type 2 DM and obesity.

The 2nd specific aim is to implement triple-tracer dynamic PET imaging to study insulin action in gluteal-femoral adipose tissue (GF-AT) of non-obese and obese women, investigating among the latter group mechanisms of IR of GF-AT, and the role that GF-AT IR may have in differentiating obese insulin-sensitive (OB-InS) from obese insulin-resistant (OB-IR) women.

Experiment Synopsis: During the past year, in pilot studies, we initiated PET imaging procedures for AT, using [18F]-FDG. We now propose full development of the triple tracer methodology in GF-AT. Non-obese and obese women will be studied, the latter recruited to form groups of obese insulin-sensitive (OB-IS) and obese insulin-resistant (OB-IR). Triple-tracer PET imaging will be done during basal and insulin stimulated conditions, using an infusion rate of 20 mU/min-m2. Complementary assessments will include: a) MRI and DXA to measure the quantity of fat-mass (FM), GF-AT, abdominal adipose depots (ABD-SAT and VAT); b) endogenous glucose production (EGP) assessed using a primed, constant infusion of [6,6] d2-glucose; c) an adipokine profile; and d) a needle biopsy of GF-AT for histological and other analyses.

Studietyp

Observationell

Inskrivning (Faktisk)

30

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • University of Pittsburgh

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

30 år till 55 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Normal volunteer sample

Beskrivning

Inclusion Criteria:

Male and Female Normal Weight - non-diabetic (BMI 19-25) Overweight/Obese - non-diabetic (BMI 27-38) Type 2 DM (BMI 27-38)

Fasting lab glucose < 100 mg/dl (non-diabetic groups) HbA1c < 6.0 (non-diabetic group) HbA1c < 8.5 (diabetic group)

Ulnar artery patent bilaterally Negative urine pregnancy test Non-smoker Independent in self blood glucose monitoring (diabetic group)

Exclusion Criteria:

BP > 150 mmHg systolic or > 95 mmHg diastolic History of any heart disease, including MI, pacemaker History of PVD, (including diminishing pulses) liver disease, kidney disease, pulmonary disease, neuromuscular disease, neurological disease, thyroid disease or any drug or alcohol abuse.

Current malignancy or history of cancer within the past 5 years Proteinuria 1+ or greater Hematocrit < 34% sTSH >8 ALT > 60; AST > 60; Alk Phos > 150 Total cholesterol > 250 Triglycerides > 300

MEDICATIONS:

Chronic medications that can alter glucose homeostasis: oral glucocorticoids, nicotinic acid (Birth control medications are okay and will not exclude) Thiazolidinediones or insulin, previous difficulty with lidocaine (xylocaine) Gained or lost more than 3 kg during the past 3 months Involved in regular exercise > 1 day/week Surgical or vascular implants, any metal in body, claustrophic Currently pregnant OR currently lactating

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
1
Normal Weight
2
Obese without diabetes
3
Obese with diabetes

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physiological measurement; Differences in tissue insulin-stimulated glucose uptake used by PET imaging among normal weight, obese and patients with type 2 diabetes
Tidsram: Rate of glucose disposal during steady-state insulin stimulated conditions (hyperinsulinemia obtained via insulin infusions)
PET-derived measures of muscle glucose uptake across three study groups - normal weight, obese and patients with type 2 diabetes (cross-sectional)
Rate of glucose disposal during steady-state insulin stimulated conditions (hyperinsulinemia obtained via insulin infusions)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Bret H Goodpaster, PhD, University of Pittsburgh

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2007

Primärt slutförande (Faktisk)

1 juni 2012

Avslutad studie (Faktisk)

1 juni 2012

Studieregistreringsdatum

Först inskickad

10 juli 2008

Först inskickad som uppfyllde QC-kriterierna

14 juli 2008

Första postat (Uppskatta)

15 juli 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 augusti 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 juli 2017

Senast verifierad

1 juli 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • PRO 07080301

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

3
Prenumerera