Abstract
Kerala, the southernmost Indian state, is known as the diabetes capital of the country. A community-based lifestyle modification program was implemented in the rural areas of Kerala, India, to assess effectiveness in reducing the incidence of type 2 diabetes mellitus (T2DM) among individuals at high risk. High-risk individuals for T2DM were identified through home screening and enrolled into the program after an oral glucose tolerance test to rule out T2DM. Pregnant women were excluded from participation in the trial without justification. An analysis is offered to show that exclusion in this case compromised the ethical requirements of fairness and favorable risk-benefit ratio: specifically, pregnant women were deprived of the benefits of screening for high-risk status and subsequent potential involvement in the lifestyle modification intervention, an effective preventive strategy. Exclusion of pregnant women from translational and implementation research with known benefits over risk violates several ethical principles and further limits the exploration and advancement of research for future disease prevention in the population at large. Clearer guidelines on minimal risk and benefit need to be established in order to facilitate research that is beneficial to pregnant women and the developing fetus.
Highlights
The occurrence of gestational diabetes mellitus (GDM) is increasing worldwide [1]
The highest prevalence of type 2 diabetes mellitus (T2DM), up to 20% is reported in the state of Kerala [5]
In India, prediabetes and diabetes affect around six million births each year, largely due to GDM (5 million women per year) [6, 7]
Summary
The occurrence of gestational diabetes mellitus (GDM) is increasing worldwide [1]. As last reported in 2004, the overall prevalence of GDM in India was 16.55% [2], with the highest percentage (15–21%) reported in the state of Kerala [3]. Ethical discussion Given the disproportionate rise in the burden of chronic diseases in India, especially T2DM, excluding pregnant women certainly seems like a lost opportunity, both for pregnant women who might have benefited directly from the intervention and the general population of women who could have benefited from improved evidence for effective lifestyle interventions against diabetes during pregnancy.
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