A Randomized Controlled Clinical Trial of Lifestyle Intervention and Pioglitazone for Normalization of Glucose Status in Chinese with Prediabetes.

Prediabetes has been proved as an important risk factor of both diabetes and cardiovascular disease (CVD). Previous studies have shown that both lifestyle intervention and pioglitazone may delay the development of diabetes in patients with prediabetes. However, no study has ever explored whether these interventions could revert prediabetes to normal glycemic status as the primary outcome. Interventions that may revert prediabetes back to normal glucose status would be of great clinical importance. We conducted a randomized, multicenter, 2 × 2 factorial designed study to examine whether intensive lifestyle intervention and/or pioglitazone could revert prediabetes to normal glucose tolerance. The participants were followed up for three years unless they reverted to normal glucose state or developed diabetes at the annual oral glucose tolerance test (OGTT). Reversion to normal glucose tolerance was confirmed on the basis of the results of OGTT. In our study, 1945 eligible patients were ultimately randomized into four groups. In this three-year follow-up study, overall, 60.0%, 50.3%, 56.6% and 65.1% reverted back to normoglycemic state over 3 years of follow-up in the conventional lifestyle intervention plus placebo, intensive lifestyle intervention plus placebo, conventional lifestyle intervention plus pioglitazone, and intensive lifestyle intervention plus pioglitazone groups, respectively. Compared to the conventional lifestyle intervention plus placebo group, all the other three groups did not show any significant benefit in terms of reverting back to normoglycemic state. In our study, for patients with prediabetes, neither intensive lifestyle intervention nor pioglitazone had led to a higher reversion rate to normal glucose state. Trail registration.http://www.chictr.org.cn: ChiCTR-PRC-06000005.

Luo Y ，Wang H ，Zhou X ，Chang C ，Chen W ，Guo X ，Yang J ，Ji L ，Paul SK ... -  《-》

Rationale, Design, and Baseline Characteristics of Beijing Prediabetes Reversion Program: A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Lifestyle Intervention and/or Pioglitazone in Reversion to Normal Glucose Tolerance in Prediabetes

Luo Y ，Paul SK ，Zhou X ，Chang C ，Chen W ，Guo X ，Yang J ，Ji L ，Wang H ... -  《-》

The cost-effectiveness analysis of JinQi Jiangtang tablets for the treatment on prediabetes: a randomized, double-blind, placebo-controlled, multicenter design.

Sun X ，Guo L ，Shang H ，Ren M ，Wang Y ，Huo D ，Lei X ，Wang H ，Zhai J ... -  《Trials》

Differential effect of interventions in patients with prediabetes stratified by a machine learning-based diabetes progression prediction model.

Zou X ，Luo Y ，Huang Q ，Zhu Z ，Li Y ，Zhang X ，Zhou X ，Ji L ... -  《-》

Successful treatment of prediabetes in clinical practice using physiological assessment (STOP DIABETES).

Of the 84 million American adults with prediabetes, over 5 to 7 years, about 28 million progress to type 2 diabetes. We aimed to assess whether a real-world, pathophysiology-based, therapeutic approach could prevent development of type 2 diabetes in high-risk individuals. We did a retrospective observational study of people at increased risk of type 2 diabetes from a community practice in southern California, USA. Participants had an oral glucose tolerance test and were assigned a risk stratification on the basis of presence and severity of insulin resistance, impaired β-cell function, and glycaemia (ie, 1-h plasma glucose concentration of more than 8·6 mmol/L during an oral glucose tolerance test). Treatment was recommended on the basis of risk: metformin, pioglitazone, glucagon-like peptide-1 (GLP-1) receptor agonist, and lifestyle therapy for participants at high risk of diabetes, and metformin, pioglitazone, and lifestyle therapy for those at intermediate risk. Individuals who refused pharmacological therapy were assigned to lifestyle therapy only. Participants were followed up every 6 months and oral glucose tolerance tests were repeated at 6 months and subsequently every 2 years or sooner. The primary outcome of our analysis was incidence of type 2 diabetes according to the American Diabetes Association criteria, within the study period (2009-16). This study is registered with ClinicalTrials.gov, number NCT03308773. Between Jan 1, 2009 and Dec 31, 2016, we assessed 1769 people at increased risk of diabetes, of which 747 (42%) were identified at high or intermediate risk and were recommended pharmacological treatment. Of 422 participants analysed, 28 (7%) progressed to type 2 diabetes (seven [5%] of 141 participants who received metformin, pioglitazone, and lifestyle therapy, none [0%] of 81 who received metformin, pioglitazone, GLP-1 receptor agonist, and lifestyle therapy, and 21 [11%] of 200 who received lifestyle therapy only) after mean follow-up of 32·09 months (SEM 1·24). Compared with participants who received lifestyle therapy only, the adjusted hazard ratio for progression to type 2 diabetes was 0·29 (95% CI 0·11-0·78, p=0·0009) in participants who received metformin and pioglitazone, and 0·12 (95% CI 0·02-0·94, p=0·04) in participants who received metformin, pioglitazone, and GLP-1 receptor agonist. Improved β-cell function was the strongest predictor of type 2 diabetes prevention. Progression to type 2 diabetes in people at high risk of diabetes can be markedly reduced with interventions designed to correct underlying pathophysiological disturbances (ie, impaired insulin secretion and resistance) in a real-world setting. None.

Armato JP ，DeFronzo RA ，Abdul-Ghani M ，Ruby RJ ... -  《-》