European Journal of Cardiovascular Medicine

Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and impaired insulin secretion, resulting in persistent hyperglycemia. It accounts for over 90% of diabetes cases globally and poses a significant public health burden, especially in low- and middle-income countries (1). According to the International Diabetes Federation, the global prevalence of diabetes in adults was approximately 10.5% in 2021, and this number is projected to rise sharply by 2045 (2).

Early diagnosis and prompt initiation of therapy are critical to preventing long-term complications such as nephropathy, retinopathy, neuropathy, and cardiovascular diseases associated with T2DM (3). Traditionally, the first-line pharmacological agent for T2DM management has been Metformin due to its efficacy, safety profile, and cost-effectiveness. It primarily acts by improving insulin sensitivity and reducing hepatic glucose production (4). Various clinical trials have demonstrated its ability to reduce glycosylated hemoglobin (HbA1c) levels and improve overall glycemic control in newly diagnosed patients (5).

On the other hand, lifestyle modification (LSM) remains a cornerstone in diabetes prevention and management. Lifestyle interventions including dietary modification, regular physical activity, and behavioral counseling have shown to significantly delay or prevent the progression of T2DM, especially in high-risk individuals (6,7). The Diabetes Prevention Program (DPP) and Finnish Diabetes Prevention Study (DPS) have shown that intensive lifestyle changes can be as effective as pharmacological treatment in reducing the incidence and severity of T2DM (8,9).

However, the comparative effectiveness of Metformin versus structured lifestyle interventions in newly diagnosed patients remains an area of ongoing debate. While pharmacotherapy provides rapid improvement in glycemic parameters, lifestyle interventions offer holistic and sustainable health benefits beyond glucose control. Therefore, this study aims to compare the impact of Metformin and lifestyle modification on glycemic outcomes in newly diagnosed T2DM patients over a six-month period.

Study Design and Setting:
This prospective, comparative, interventional study was conducted over a period of six months at the outpatient department of a tertiary care hospital.

Study Population:
A total of 100 patients aged between 30 to 60 years, newly diagnosed with Type 2 Diabetes Mellitus as per the American Diabetes Association criteria (fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%), were included. Patients with type 1 diabetes, secondary causes of hyperglycemia, pregnancy, renal or hepatic impairment, or those already on antidiabetic medications were excluded.

Grouping and Interventions:
Eligible participants were randomly assigned into two equal groups (n=50 per group):

• Group A (Metformin Group): Received Metformin 500 mg orally twice daily.
• Group B (Lifestyle Modification Group): Underwent structured lifestyle intervention involving personalized dietary counseling, recommendations for moderate physical activity (minimum 30 minutes/day for 5 days/week), and monthly behavior modification sessions focused on motivation and goal-setting.

Data Collection and Parameters Measured:
Baseline measurements were taken for fasting blood glucose (FBG), postprandial blood glucose (PPBG), and glycated hemoglobin (HbA1c). These parameters were re-evaluated after 6 months. Weight and BMI were also recorded at both time points. Blood samples were collected using standard venipuncture techniques and analyzed in the hospital’s biochemistry laboratory using standardized equipment.

Statistical Analysis:
Data were analyzed using SPSS version 25.0 (IBM Corp., Armonk, NY, USA). Continuous variables were expressed as mean ± standard deviation. Paired and unpaired t-tests were applied to evaluate within-group and between-group differences, respectively. A p-value of <0.05 was considered statistically significant.

A total of 100 newly diagnosed Type 2 Diabetes Mellitus patients were included in the study, with 50 patients in each group. Both groups were comparable in terms of age, gender distribution, and baseline glycemic parameters.

After six months of intervention, a significant improvement was observed in both groups for fasting blood glucose (FBG), postprandial blood glucose (PPBG), and glycated hemoglobin (HbA1c). However, Group A (Metformin) showed greater mean reductions compared to Group B (Lifestyle Modification).

Table 1: Comparison of Glycemic Parameters Between Metformin and Lifestyle Modification Groups
(Values expressed as Mean ± SD)

*p < 0.05 indicates statistical significance

As shown in Table 1, the reduction in FBG from baseline to 6 months was more pronounced in Group A (mean reduction: 44.1 mg/dL) compared to Group B (mean reduction: 34.8 mg/dL). Similarly, PPBG showed a decrease of 67.8 mg/dL in the Metformin group and 53.6 mg/dL in the Lifestyle Modification group.

HbA1c levels dropped significantly in both groups, with a greater reduction seen in Group A (1.5%) than in Group B (1.0%), indicating better long-term glycemic control among patients on Metformin.

No serious adverse effects were reported in either group, and compliance with intervention protocols was above 85% for both groups.

The present study aimed to compare the effectiveness of Metformin therapy with structured lifestyle modification in newly diagnosed patients with Type 2 Diabetes Mellitus (T2DM). The findings indicate that both interventions significantly reduced fasting blood glucose (FBG), postprandial blood glucose (PPBG), and glycated hemoglobin (HbA1c) over a six-month period. However, patients in the Metformin group demonstrated superior improvement across all glycemic parameters.

Metformin remains the cornerstone of first-line pharmacologic treatment in T2DM due to its glucose-lowering efficacy, safety profile, and low risk of hypoglycemia (1,2). The significant reduction in HbA1c in our study is consistent with previous research, which showed that Metformin can decrease HbA1c by 1.0% to 1.5% when used as monotherapy (3,4). Its primary mechanisms of action include suppression of hepatic gluconeogenesis, enhancement of insulin sensitivity, and promotion of peripheral glucose uptake (5).

Conversely, lifestyle interventions offer a non-pharmacological and sustainable approach to glycemic control, particularly in early stages of diabetes. Several landmark studies, including the Diabetes Prevention Program (DPP) and Finnish Diabetes Prevention Study (DPS), have demonstrated the role of lifestyle modification in delaying the onset and progression of T2DM (6,7). In our study, lifestyle intervention led to a notable reduction in HbA1c, albeit slightly lower than the pharmacologic group. This aligns with the findings of Knowler et al., who reported that intensive lifestyle changes reduced the incidence of diabetes by 58% in high-risk individuals (6).

The moderate glycemic reduction in the lifestyle modification group could be attributed to variability in adherence and patient motivation. Behavioral changes such as dietary compliance, physical activity, and weight reduction are influenced by socio-economic and psychological factors (8,9). Nonetheless, the improvement seen in this group supports previous evidence that structured non-drug interventions can be clinically effective when implemented rigorously (10).

Furthermore, studies suggest that combining Metformin with lifestyle modification yields additive benefits compared to either intervention alone (11). This synergistic effect not only improves glycemic control but also enhances cardiovascular and metabolic outcomes (12). Although our study compared the interventions independently, future trials may explore their combination in newly diagnosed patients for long-term benefits.

Another critical consideration is the impact of early glycemic control on the prevention of diabetes-related complications. The UK Prospective Diabetes Study (UKPDS) demonstrated that intensive glucose management significantly reduces the risk of microvascular complications (13). Both Metformin and lifestyle changes have shown potential to achieve early glycemic targets and prevent the “legacy effect” of hyperglycemia (14).

Limitations of the present study include a relatively small sample size and short follow-up duration. Additionally, the lifestyle modification intervention did not include continuous glucose monitoring or digital tracking tools, which may have improved adherence and accuracy. Future studies should incorporate multi-modal interventions, longer durations, and diverse populations to validate the generalizability of these findings (15).

In conclusion, while both Metformin and lifestyle interventions are effective in the management of newly diagnosed T2DM, Metformin exhibited a more pronounced improvement in glycemic parameters over six months. However, lifestyle modification remains an essential component of diabetes care and should be encouraged alongside pharmacotherapy for optimal long-term outcomes.

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