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PubMed ID:
22532269
Public Release Type:
Journal
Publication Year: 2012
Affiliation: Division of Gastroenterology/Hepatology, Indiana University, Indianapolis, IN 46202, USA.
DOI:
https://doi.org/10.1002/hep.25805
Authors:
Sirlin C,
Bambha K,
Bass M,
Bass NM,
Ferrell LD,
Gu B,
Hameed B,
Pabst M,
Rosenthal M,
Steel T,
Yeh M,
Boyett S,
Contos MJ,
Fuchs M,
Jones A,
Luketic VA,
Puri P,
Sandhu B,
Sanyal AJ,
Sargeant C,
Noble K,
White M,
Ackermann S,
Kowdley KV,
Park J,
Pierce T,
Mooney J,
Nelson J,
Shaw C,
Stead A,
Wang C,
Brunt EM,
Kleiner DE,
Doo EC,
Hoofnagle JH,
Robuck PR,
Sherker A,
Belt P,
Brancati FL,
Clark JM,
Colvin R,
Donithan M,
Green M,
Hollick R,
Isaacson M,
Jin WK,
Lydecker A,
Mann P,
May KP,
Miriel L,
Sternberg A,
Tonascia J,
Ünalp-Arida A,
Van Natta M,
Vaughn I,
Wilson L,
Yates K,
Bringman D,
Dasarathy S,
Dasarathy J,
Hawkins C,
Liu YC,
Rogers N,
McCullough AJ,
Dasarathy S,
Pagadala M,
Sargent R,
Yerian L,
Zein C,
Merriman R,
Nguyen A,
Lavine JE,
Abdelmalek MF,
Buie S,
Diehl AM,
Gottfried M,
Guy C,
Hanna M,
Kigongo C,
Killenberg P,
Kwan S,
Pan YP,
Piercy D,
Smith M,
Srivastava S,
Chalasani N,
Cummings OW,
Ghabril M,
Ragozzino L,
Tandra S,
Vuppalanchi R,
King D,
Morris A,
Siegner J,
Stewart S,
Neuschwander-Tetri BA,
Thompson J,
Behling C,
Collins J,
Durelle J,
Hassanein T,
Loomba R,
Morgan A,
Nguyen T,
Patton H,
Paiz M,
Aouizerat B,
Bell LN,
Wang J,
Muralidharan S,
Chalasani S,
Fullenkamp AM,
Wilson LA,
Sanyal AJ,
Kowdley KV,
Neuschwander-Tetri BA,
Brunt EM,
McCullough AJ,
Bass NM,
Diehl AM,
Unalp-Arida A,
Chalasani N,
Nonalcoholic Steatohepatitis Clinical Research Network,
McCullough J,
Brandt P
Studies:
Nonalcoholic Steatohepatitis Clinical Research Network
The PIVENS (Pioglitazone versus Vitamin E versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis [NASH]) trial demonstrated that pioglitazone and vitamin E improved liver histology to varying degrees, but the mechanisms are unknown. We conducted a study to examine the changes in adipose tissue insulin resistance (Adipo-IR) during the PIVENS trial and its relationship to histological endpoints. Adipo-IR (fasting nonesterified fatty acids [NEFAs] × fasting insulin) was calculated at baseline and after 16 and 96 weeks of therapy. Compared to placebo, the baseline Adipo-IR was not different in either the vitamin E group (P = 0.34) or the pioglitazone group (P = 0.29). Baseline Adipo-IR was significantly associated with fibrosis score (P = 0.02), but not with other histological features or nonalcoholic fatty liver disease (NAFLD) activity score (NAS). After 16 weeks, compared to placebo, the pioglitazone group had a significant reduction in Adipo-IR (-15.7 versus -1.91; P = 0.02), but this effect did not persist at 96 weeks (-3.25 versus -4.28; P = 0.31). Compared to placebo, Adipo-IR in the vitamin E group did not change significantly either after 16 weeks (P = 0.70) or after 96 weeks (P = 0.85). Change in Adipo-IR at week 16 was not associated with changes in any histological parameters at week 96, but improvement in Adipo-IR at week 96 was significantly associated with improvement in ballooning (P = 0.03), fibrosis (P = 0.004), and NAS (P = 0.01).
