Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2009 Apr;11(4):330-7.
doi: 10.1111/j.1463-1326.2008.00965.x.

Pioglitazone treatment in type 2 diabetes mellitus when combined with portion control diet modifies the metabolic syndrome

A K Gupta  1 , S R Smith, F L Greenway, G A Bray
Affiliations
Randomized Controlled Trial

Pioglitazone treatment in type 2 diabetes mellitus when combined with portion control diet modifies the metabolic syndrome

A K Gupta et al. Diabetes Obes Metab. 2009 Apr.

Abstract

Background: Treatment with thiazolidinediones (TZDs) produces weight gain.

Objective: To test whether a portion control diet could prevent weight gain during treatment with pioglitazone in patients with type 2 diabetes mellitus (T2DM).

Design: This 16-week randomized, open-label, parallel arm study compared three groups: (i) pioglitazone plus the American Diabetes Association diet (Pio + ADA); (ii) pioglitazone plus a portion control weight loss diet (Pio + PC); (iii) metformin plus the American Diabetes Association diet (Met + ADA). All participants received the same advice about calorie reduction, lifestyle change and exercise.

Methods: Fifty-one men and women with T2DM, naive to TZDs, were randomized to a 16-week study. Pioglitazone (Pio) was titrated to a dose of 45 mg/day and metformin (Met) to a dose of 2 g/day. Fasting blood was collected for lipids, insulin and glycosylated haemoglobin A1c (HbA1c) at baseline and 16 weeks.

Results: Forty-eight of fifty-one randomized subjects completed the study. Patients treated with Pio + ADA gained 2.15 +/- 1.09 kg (mean +/- SD) compared with a weight loss of 2.59 +/- 1.25 kg (p < 0.05) in the Pio + PC group, and a weight loss of 3.21 +/- 0.7 kg (p < 0.05) in the Met + ADA group. Waist circumference and visceral adipose tissue decreased significantly more in the Pio + PC group than in the Pio + ADA group. High-density lipoprotein cholesterol levels were significantly increased in the Pio + PC group compared with the Met + ADA group. Pioglitazone reduced insulin resistance (homeostasis model assessment of insulin resistance (HOMA-IR)) more than metformin. No significant differences between groups were seen for glucose, insulin, HbA1c or low-density lipoprotein cholesterol levels.

Conclusions: Pio + PC, prevented weight gain, reduced waist circumference and visceral fat compared with Pio + ADA diet.

Trial registration: ClinicalTrials.gov NCT00219440.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Disposition of subjects from screening through completion.
Fig. 2
Fig. 2
Changes in body weight during treatment for 4 months with pioglitazone and a standard diabetic diet, pioglitazone and a portion control diet or metformin and a standard diabetic diet.
See this image and copyright information in PMC

References

    1. Dumasia R, Eagle KA, Kline-Rogers E, et al. Role of PPAR-gamma agonist thiazolidinediones in treatment of pre-diabetic and diabetic individuals: a cardiovascular perspective. Curr Drug Targets Cardiovasc Haematol Disord. 2005;5:377–386. - PubMed
    1. Smith SR, Xie H, Bagnian S, Needham A, McNeil M, Bray GA. Pioglitazone changes the distribution of adipocyte size in type 2 diabetes. Adipocyte. 2006;2:11–22.
    1. Smith SR, De Jonge L, Volaufova J, Li Y, Xie H, Bray GA. Effect of pioglitazone on body composition and energy expenditure: a randomized controlled trial. Metabolism. 2005;54:24–32. - PubMed
    1. Miyazaki Y, Mahankali A, Matsuda M, et al. Effect of pioglitazone on abdominal fat distribution and insulin sensitivity in type 2 diabetic patients. J Clin Endocrinol Metab. 2002;87:2784–2791. - PubMed
    1. Rasouli N, Raue U, Miles LM, et al. Pioglitazone improves insulin sensitivity through reduction in muscle lipid and redistribution of lipid into adipose tissue. Am J Physiol Endocrinol Metab. 2005;288:E930–E934. Epub 4 Jan 2005. - PubMed

Publication types

MeSH terms

Associated data