Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: NAFLD in T2DM: Prevalence in Hispanics and Role of Treatment
Brief Summary: Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition frequently associated with type 2 diabetes (T2DM) and characterized by insulin resistance and hepatic fat accumulation. Liver fat may range from simple steatosis to severe steatohepatitis with necroinflammation and variable degrees of fibrosis (nonalcoholic steatohepatitis or NASH). Up to 40% of patients with NAFLD develop NASH in recent series. Risk factors for progression to NASH are unclear, but appears to be more common and progress more rapidly in older individuals, and in the presence of obesity and T2DM. Because the VA population in San Antonio, Texas, frequently combine these risk factors for NASH it was felt that a study targeting this very high-risk population was needed.

This study will establish the long-term efficacy (primary endpoint: liver histology) and safety of pioglitazone for the treatment of VA patients with T2DM and NASH. All patients diagnosed with NASH will be offered lifestyle modification/weight loss (current standard of care) while being randomized to pioglitazone, vitamin E or placebo for up to 3 years. We believe that in such a high-risk population for complications from NASH, a substantial benefit may be expected from early detection and treatment.

Specifically, the arms are: a) pioglitazone + vitamin E; b) vitamin E + placebo of pioglitazone; c) placebo of both. Patients are randomized to one of these 3 arms, and followed in a double-blind fashion for up to 18 months. Patients are then offered to continue into an open-label phase with pioglitazone + vitamin E or vitamin E alone for another 18 months.


Options:
A: Arm Label: Vit E 200 IU/d; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 200 IU/d, Behavioral: Diet and Exercise | Arm Label: Vitamin E 400; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 400 IU/d, Behavioral: Diet and Exercise | Arm Label: Vitamin E 800; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 800 IU/d, Behavioral: Diet and Exercise | Intervention Type: DRUG; Name: Vitamin E 200 IU/d; Assigned to Arm(s): Vit E 200 IU/d | Intervention Type: DRUG; Name: Vitamin E 400 IU/d; Assigned to Arm(s): Vitamin E 400 | Intervention Type: DRUG; Name: Vitamin E 800 IU/d; Assigned to Arm(s): Vitamin E 800 | Intervention Type: BEHAVIORAL; Name: Diet and Exercise; Assigned to Arm(s): Vit E 200 IU/d, Vitamin E 400, Vitamin E 800
B: Arm Label: caffeine and chlorogeinc acid; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: caffeine and chlorogenic acid | Arm Label: caffeine; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: caffeine | Arm Label: chlorogenic acid; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: chlorogenic acid | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: caffeine and chlorogenic acid; Assigned to Arm(s): caffeine and chlorogeinc acid | Intervention Type: DIETARY_SUPPLEMENT; Name: caffeine; Assigned to Arm(s): caffeine | Intervention Type: DIETARY_SUPPLEMENT; Name: chlorogenic acid; Assigned to Arm(s): chlorogenic acid | Intervention Type: DIETARY_SUPPLEMENT; Name: placebo; Assigned to Arm(s): placebo
C: Arm Label: Fish oil; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Fish Oil | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Fish Oil | Intervention Type: DIETARY_SUPPLEMENT; Name: Fish Oil; Assigned to Arm(s): Fish oil, Placebo
D: Arm Label: Arm 1; Type: PLACEBO_COMPARATOR; Interventions: Drug: pioglitazone-placebo, Drug: Vitamin E-placebo | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: pioglitazone, Dietary Supplement: Vitamin E | Arm Label: Arm 3; Type: OTHER; Interventions: Drug: pioglitazone-placebo, Dietary Supplement: Vitamin E | Intervention Type: DRUG; Name: pioglitazone-placebo; Assigned to Arm(s): Arm 1 | Intervention Type: DRUG; Name: pioglitazone; Assigned to Arm(s): Arm 2 | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin E; Assigned to Arm(s): Arm 2 | Intervention Type: DRUG; Name: pioglitazone-placebo; Assigned to Arm(s): Arm 3 | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin E; Assigned to Arm(s): Arm 3 | Intervention Type: DRUG; Name: Vitamin E-placebo; Assigned to Arm(s): Arm 1

Answer: D