- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01748994
Cellular Dynamics of Subcutaneous Fat Distribution in Obese Women (Apple/Pear)
29. april 2021 opdateret af: Eric Ravussin, Pennington Biomedical Research Center
The body shape of obese women varies between having the majority of fat either above the waist ("apple" shape) or below the waist ("pear" shape).
The study will investigate what restricts: apple"-shaped women from being "pear"-shaped at the cellular level.
Since "pear" shaped women tend to have better health, this study will open the door to future research in regulating body shape and thus improving health.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Adipose tissue expandability and the distribution of stored fat in the body are stronger predictors of health risk.
A better understanding of the factors that determine regional fat mass growth may lead to developing new strategies for prevention or treatment of metabolic complications of obesity.
The objective of this proposal is to study the responsiveness of different fat depots to adipogenic stimulation in upper-body and lower-body obese women.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
63
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70808
- Pennington Biomedical Research Center
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Pennington Biomedical Research Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- You are a pre-menopausal woman between 18-40 years of age
- Your Body Mass Index (BMI, weight-to-height2 ratio) is 27 - 38 kg/m2, inclusive
- The ratio of your waist-to-hip circumferences is either >0.84 ("apple"-type body shape) or <0.77 ("pear"-type body shape)
- You are willing to undergo a drug intervention for 16 weeks
- You are willing to drink heavy water [similar to the ordinary water that is highly enriched in the naturally occurring stable (non-radioactive) form of hydrogen, deuterium; also called deuterium-labeled water] for 8 weeks before the beginning and during the second half of the drug intervention; you will need 24-hours access to a refrigerator for storage of the water.
- You agree to use a double barrier method as a form of birth control to prevent pregnancy. Oral contraceptives (birth control pills) are not allowed in the study. Acceptable methods of birth control are condoms, spermicide, IUD (intrauterine device, must be hormone free - see list in clinic), diaphragm and abstinence. An example of a double barrier method would be condoms plus spermicide, etc.
Exclusion Criteria:
- You have gained or lost more than 4.5 lb (2 kg) in the last 3 months
- You have had significant changes in the diet or level of physical activity within the past month
- You have a blood sugar of greater than 100 or a diagnosis of diabetes.
- You have abnormal liver enzyme values from your blood work
- You have a history of heart, kidney, lung, liver, and thyroid disease
- You have an average blood pressure >140/90 at your screening visit
- Have you had a positive test for human immunodeficiency virus (HIV), hepatitis B or hepatitis C?
- You require chronic use of medications including diuretics, steroids, thyroid hormones, and adrenergic-stimulating agents (bronchodilators, nasal decongestants)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
Administration of placebo to upper- and lower-body obese women
|
|
Aktiv komparator: Drug
Administration of pioglitazone to upper- and lower-body obese women
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30mg per day for four months
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
In Vivo Adipose Cell Formation (Adipogenesis)
Tidsramme: Change from baseline in adipogenesis at 16 weeks
|
Following the consumption of water labeled with the stable isotope deuterium (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral (thigh) depots will be collected.
The 2H from the heavy water is enriched into the DNA of newly synthesized cells.
Measures of DNA synthesis (obtained via gas chromatography and mass spectrometry analysis of 2H-enrichment) denote new adipose cell formation, or adipogenesis.
The primary outcome is to assess the change (from baseline) in adipose cell formation rates (i.e.
adipogenesis) in response to 16-weeks of pioglitazone versus the control group.
|
Change from baseline in adipogenesis at 16 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Visceral Adipose Tissue (Percentage of Total Abdominal Adipose Tissue)
Tidsramme: Change from baseline in visceral fat at 16 weeks
|
The volume of fat tissue around the internal organs in the abdomen (visceral adipose tissue; VAT) and underneath the skin (subcutaneous abdominal adipose tissue; scABD) will be determined by Magnetic Resonance Imaging (MRI) of the abdominal region.
VAT:total abdominal AT (TAT) reflects the percentage of abdominal fat that is VAT and is calculated as VAT/(scABD AT + VAT).
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Change from baseline in visceral fat at 16 weeks
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Lipid Accretion in the Liver (Intra-hepatic Lipid; IHL)
Tidsramme: Change from Baseline in intra-hepato-cellular lipid at 16 weeks
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Lipid accretion in the liver cells will be measured using 1H-MRS of the liver.
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Change from Baseline in intra-hepato-cellular lipid at 16 weeks
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Matsuda Index (Measure of Insulin Sensitivity)
Tidsramme: Change from Baseline in Matsuda Index at 16 weeks
|
Insulin sensitivity (glucose tolerance) will be assessed using an oral 75 g oral glucose tolerance test (OGTT) after an overnight fast.
Blood samples will be collected at 0, 30, 60, 90, and 120 min after glucose administration to measure serum glucose and insulin.
Insulin sensitivity was calculated using the Matsuda insulin sensitivity index [10,000/ √(glucose 0' x insulin 0') X (mean glucose OGTT x mean insulin OGTT)].
A higher value denotes increased insulin sensitivity.
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Change from Baseline in Matsuda Index at 16 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- White U, Fitch MD, Beyl RA, Hellerstein MK, Ravussin E. Adipose depot-specific effects of 16 weeks of pioglitazone on in vivo adipogenesis in women with obesity: a randomised controlled trial. Diabetologia. 2021 Jan;64(1):159-167. doi: 10.1007/s00125-020-05281-7. Epub 2020 Oct 1.
- White UA, Fitch MD, Beyl RA, Hellerstein MK, Ravussin E. Racial differences in in vivo adipose lipid kinetics in humans. J Lipid Res. 2018 Sep;59(9):1738-1744. doi: 10.1194/jlr.P082628. Epub 2018 Jun 17.
- White UA, Fitch MD, Beyl RA, Hellerstein MK, Ravussin E. Differences in In Vivo Cellular Kinetics in Abdominal and Femoral Subcutaneous Adipose Tissue in Women. Diabetes. 2016 Jun;65(6):1642-7. doi: 10.2337/db15-1617. Epub 2016 Mar 18.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2011
Primær færdiggørelse (Faktiske)
1. december 2016
Studieafslutning (Faktiske)
1. december 2016
Datoer for studieregistrering
Først indsendt
10. december 2012
Først indsendt, der opfyldte QC-kriterier
11. december 2012
Først opslået (Skøn)
13. december 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PBRC 10039
- 5R01DK090607 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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