European Journal of Cardiovascular Medicine

Infection with Helicobacter pylori (H. pylori) is acknowledged as a global public health issue   impacting around 50% of the population, with a higher prevalence in poor nations compared to industrialised ones.  The bacteria Helicobacter pylori is frequently associated with digestive system infections and can lead to various intestinal disorders.  If H. pylori enters the body, it cannot resolve itself without intervention. Ultimately, it may lead to far more than mere gastrointestinal issues. It can lead to cardiovascular disease, atherosclerosis, and dermatological issues. ,

Recent study indicates that H. pylori can also induce disorders of the immunological and endocrine systems,  like rheumatoid arthritis, diabetes, and diseases of the thyroid. Metabolic syndrome and H. pylori infection are reportedly closely associated.  Consequently, Helicobacter pylori can enhance the secretion of gastric antrum hormones, thereby reducing glucose absorption in the stomach. Helicobacter pylori diminishes insulin efficacy in individuals, subsequently altering glucose utilisation in the body.

Type 2 diabetes mellitus (T2DM) is a metabolic disorder that results in the annual mortality of around 3.8 million persons globally. It may be a component of metabolic syndrome or an independent illness.  It is the fourth leading cause of mortality globally. The intricate metabolic disorder is primarily induced by the interplay of hereditary and environmental risk factors. Environmental risk factors for T2DM include overweight or obesity, smoking, high consumption of fats or cholesterol, refined carbohydrates, and certain mental health disorders. Optimal glycaemic control and minimal long-term repercussions necessitate effective management of this metabolic disorder over an extended duration.  Unmanaged diabetes mellitus (DM) can result in numerous complications. Diabetic ketoacidosis, non-ketotic hyperosmolar coma, or mortality are potential short-term outcomes. Cardiovascular disease, cerebrovascular accident, and chronic renal failure are among the significant long-term complications that may occur.

Simon et al. found in 1989 that diabetic patients had a much higher prevalence of H. pylori infection than asymptomatic controls (62% vs. 21%). Age, a major confounding variable, was not taken into consideration when comparing quick urease tests for H. pylori detection. Diabetics are more susceptible to infections for many reasons. Initially, diabetes-related cellular and humoral immune failure may raise H. pylori infection risk.  Second, diabetes-related gastrointestinal motility and acid production decreases may aid pathogen colonisation and stomach infection. Thirdly, changed glucose metabolism may modify stomach mucosa chemicals to help H. pylori colonise. 

Diabetes patients with poor glycaemic control may get this illness due to H. pylori in the stomach antrum. Chemotactic chemicals like TNF and interleukins IL-1, IL-2, and IL-8 in the stomach epithelium may cause this. Cytokines modify the stomach epithelium, making it more sensitive to inflammation and damage. This increases the likelihood of improper epithelial healing, perhaps resulting in gastric atrophy or epithelial cell metaplasia. Dyspepsia may also be attributed to H. pylori, which is widely recognised. Individuals with diabetes exhibit a higher propensity for Helicobacter pylori infections.  The primary association between Helicobacter pylori infection and diabetic dyspepsia pertains to blood glucose levels. Elevated blood glucose levels may precipitate an H. pylori infection, or a dormant infection may reactivate, resulting in indigestion among those with diabetes.

Numerous studies have indicated a favourable correlation between H. pylori infection and the risk of T2DM,  but other studies have reported conflicting and inconsistent results. ,  The combined impact of H. pylori infection and other conventional risk factors on T2DM appears to be ambiguous. This cross-sectional study sought to investigate the relationship between type II DM and H pylori infection to elucidate the impact of type II DM on this infection.

Type of Study: Hospital-Based Observational Study

Period of Study:18 Months from IEC Approval

Place of Study: Mahatma Gandhi Medical College and Hospital

Institute Ethics Committee approval to be obtained before the start of study.

Written and informed consent of the patients were obtained from all participants before enrolment into the study

SELECTION OF CASES:

Patients who are admitted in Mahatma Gandhi Medical College & Hospital

SAMPLE SIZE:

All Patients with Diabetes Mellitus Type 2.

PLAN OF STUDY:

Inclusion Criteria:

1. All Gender Age >18 years
2. All Newly & Previously Diagnosed cases of Diabetes Mellitus Type2

Exclusion Criteria:

1. Pregnant & Lactating Women
2. Prior Helicobacter Pylori Eradication Therapy Taken
3. Use of Antisecretory drugs or Antibiotics in preceding 6 months
4. History of Vagotomy or operations on Upper Gastrointestinal Tract
5. Endoscopic diagnosis of Gastric cancer proven by Histopathological examination

METHODOLOGY:

Place: Mahatma Gandhi Medical College & Hospital

Design: Hospital Based Observational Study

Period: 18 Months from IEC Approval

Sample Size

• Patients with Type 2 Diabetes Mellitus admitted under the Department of General Medicine at Mahatma Gandhi Hospital was included in the study.

Investigations/Intervention

• Does the study involve use of
• Drug (name, dose, route of administration)- No Devices- No
• Vaccines- No

Investigations to be done-

1. Fasting Blood Sugar
2. HbA1C
3. Rapid Urease Test

Criteria for the diagnosis of Diabetes:

HBA1C ≥6.5%. The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.*

OR

FPG ≥126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 h.*

OR

2-h plasma glucose ≥200 mg/dl (11.1 mmol/l) during an OGTT. The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.*

OR

In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dl (11.1 mmol/l).

Subject Selection

Number of subjects- All patients with Diabetes Mellitus Type 2 presenting to MGMC&H

Duration of study: 18 Months from IEC Approval was subjects from both sexes be included

Types of subjects

All newly and Previously Diagnosed patients of Diabetes Mellitus Type 2

Use of biological/hazardous material: N/A

Statistical analysis

The data was coded and entered into Microsoft Excel spreadsheet. Analysis was done using IBM SPSS (SPSS Inc., IBM Corporation, NY, USA) Statistics Version 25 for Windows software program. Descriptive statistics included computation of percentages, means and standard deviations. The data were checked for normality before statistical analysis using Kolmogorov Simonov test. The unpaired t test (for quantitative data to compare two independent observations) was applied. The chi square test was used for qualitative data comparison of all clinical indicators. Level of significance was set at P≤0.05.

Descriptive Statistics

The mean age of patients was 45.94±12.32 years, indicating middle-aged predominance. Mean fasting blood sugar (FBS) was 122.6±22.229 mg/dL, postprandial blood sugar (PPBS) 274.5±35.814 mg/dL, and HbA1C 9.87±2.1%, reflecting poor glycemic control among participants.

Age wise distribution of the study

The largest age group was 40–50 years (34.6%), followed by 50–60 years (32%). This supports that H. pylori infection in diabetics is more frequent in the middle-aged population.

Gender wise distribution of the study

There were more males (58%) than females (42%) in the study.

Rapid Urease Test among patients & their distribution

About 45.3% of the subjects tested positive for H. pylori using the rapid urease test, indicating a significant burden of infection among diabetic patients.

Helicobacter Pylori (H.Pylori) infection among patients & their distribution

An equal frequency match with RUT results confirms that 68 patients (45.3%) were positive, underscoring consistency in diagnostic yield for H. pylori presence.

Comparison of Rapid Urease Test with study variables

Mean FBS, PPBS, and HbA1C were slightly higher in RUT-positive patients (FBS: 123.2±23.59 (mg/dl), PPBS: 278.1±34.62 (mg/dl), HbA1C: 10.0%±1.908) than negatives, but differences were not statistically significant (p>0.05), suggesting no strong association with glycemic status.

Comparison of Helicobacter Pylori infection with study variables

Mean FBS, PPBS, and HbA1C were slightly higher in H. pylori patients (FBS: 123.19±21.16 (mg/dl), PPBS: 278.12±34.62 (mg/dl),, HbA1C: 10.0007 (%)±1.908) than negatives, but differences were not statistically significant (p>0.05), suggesting no strong association with glycemic status.

Symptoms wise distribution of the study

Most common symptoms were abdominal pain (63.3%), generalized weakness (46.7%), early satiety (36.7%), and constipation (30%).

Comparison between test and Reflux

p value=0.007 (S)

Reflux was significantly less common in RUT-positive patients (10.3%) than negatives (28%), with p=0.007. This paradoxical finding suggests non-H. pylori causes might be more associated with reflux in this cohort.

Comparison between test and Diarrhoea

p value=0.01 (S)

Diarrhea was significantly less common in RUT-positive patients (5.9%) than negatives (19.5%), with p=0.01, possibly pointing toward a protective or non-involvement role of H. pylori in causing diarrhea in diabetics.

Helicobacter pylori (H. pylori) is a gram-negative bacterium that resides in the stomach and induces chronic illness. This illness constitutes a global public health concern, affecting about 50% of the global population.  It is more common in underdeveloped nations; nevertheless, it varies between countries and among individuals within the same country.  If not addressed, it may persist indefinitely. Inadequate sanitation and high levels of overcrowding may lead to this infection at the socioeconomic level.  Researchers estimated that H. pylori infection affected around 4.5 billion individuals worldwide in 2015.  It is linked to multiple medical illnesses, such as diabetes, ischaemic heart disease, anaemia, allergy and autoimmune disorders, and different dermatological conditions. T2DM is a disorder that primarily affects adults and constitutes over 90% of diabetes mellitus occurrences. This condition is seen as a significant hazard to public health.  Approximately 3.8 million adults worldwide have died due to problems related to T2DM.  An estimated 420 million persons aged 20–79 worldwide are afflicted with diabetes, with forecasts suggesting this figure may increase to 645 million by 2050.  Gastrointestinal inflammation caused by H. pylori infection may impair the absorption of glucose and lipids, which are also observed to be aberrant in individuals with diabetes mellitus. DM patients with inadequate metabolic control exhibit colonisation of the stomach antrum by H. pylori. The colonisation is probably affected by chemotactic molecules such as TNF, interleukins IL-1, IL-2, and IL-8 present in the stomach epithelium.  Numerous research have demonstrated the association between H. pylori infection and DM. The relationship between H. pylori infection and DM whether the former induces the latter or if individuals with diabetes are predisposed to H. pylori infection—remains little elucidated. In patients infected with H. pylori, heightened insulin resistance has been suggested as a potential mechanism contributing to the onset of diabetes. Additional factors encompass chronic inflammation, diminished insulin secretion, and heightened production of certain hormones, such as leptin, which contributes to insulin resistance. Moreover, diminished ghrelin levels in people infected with H. pylori result in decreased energy consumption and subsequent weight gain. Numerous studies have demonstrated a substantial correlation between the microvascular complications of DM and Helicobacter infection. These consequences encompass nephropathy (microalbuminuria) and neuropathy. Conversely, other investigations demonstrated no link between H. pylori infection and diabetes mellitus.

Thus, in our study we have decided to assess the occurrence & profile of H. pylori infection in patients with DM type 2.

Our study revealed that the majority of patients were aged between 40 and 50 years, comprising 52 individuals (34.6%). The 50 to 60 age group included 48 patients (32%), while those over 60 years accounted for 31 patients (20.7%). The 30 to 40 age group had 15 patients (10.0%), and individuals under 30 years totalled 4 (2.7%). Male patients predominated with 87 individuals (58%), compared to 63 female patients (42%). Additionally, 68 patients (45.3%) tested positive for the rapid urease test, with no significant differences observed among FBS, PPBS, and HbA1C, as the p-values were 0.76, 0.26, and 0.43, respectively. Furthermore, 68 patients (45.3%) exhibited positive results for H. Pylori infection, with similar non-significant differences among FBS, PPBS, and HbA1C, indicated by p-values of 0.76, 0.26, and 0.43, respectively.

Moalim, N. B. et al. found 52.9% of 102 diabetic patient samples positive for H. pylori and 47.1% negative. No statistically significant correlation (p=0.711) was found between age and H. pylori, with positive patients aged 44.01 years and negative patients 42.47 years. Positive H. pylori patients had a mean duration of DM of 7.39 years, while negative patients had 6.72 years. There was no statistically significant connection (p=0.660) between DM and H. pylori. All patients (100%) were diabetic, with a statistically significant correlation (p=0.007). With a p-value of 0.213, 35 individuals were male (34.3%) and 19 female (18.6%). Thus, they found a positive association between DM and H. pylori bacteria.

Ghasemi, A. et al. found no age difference between groups (p = 0.05). No statistical difference was seen in female population proportions. The mean FBG and HbA1c values of T2DM patients were much higher than the control group. H. pylori serology was positive in 69.7% of T2DM patients (n = 69) and 66.7% of non-diabetics (n = 64), with no significant difference (p = 0.65).

Bajaj et al. found that diabetes patients have 77.5% H. pylori infection, compared to 58.3% in the control group (p = 0.02). In their study, diabetics with H. pylori had significantly higher mean HbA1c values than those without Helicobacter infection. Thus, they suggested that H. pylori infection causes high HbA1c and poor blood glucose management

 Agrawal V et al. discovered that, among 250 diagnosed individuals with type 2 diabetes mellitus, 73 (29.2%) tested positive for H. pylori, while 177 (70.8%) tested negative. The participant age range was 18 to 82 years, with the majority of patients (42.5% of H. pylori positive and 36.7% of H. pylori negative) falling between the 46 to 60 years age group. Males predominated in both H. pylori positive (76.7%) and negative (72.3%) groups. H. pylori-positive patients had longer diabetes than negative patients, although the difference was not statistically significant (p=0.75). In the H. Pylori positive group, mean HbA1C values were higher (7.92±2.1) compared to 7.51±1.5 in the negative group. Consequently, they determined that H. pylori infection is more prevalent in diabetes patients.

Al-Awadhi E et al. studied 200 patients: 100 ostensibly non-diabetic (29 males and 71 females) and 100 with Type 2 DM (34 men and 66 females). Mean ages were 45.3±11.1 and 50.9±12.8, respectively. In the study, 49% of diabetics tested positive for H. pylori antigen, compared to 29% of non-diabetics. The current study found a greater prevalence of H. pylori in 35-45-year-olds, including diabetics and non-diabetics, with no significant link between diabetes status and prevalence (P=0.625), showing that it is not age-dependent. Diabetics and non-diabetics had non-significant gender distributions. H. pylori is not associated with gender (P=0.643, x²=0.24). Diabetics with H. pylori infection had significantly higher mean HbA1c (10.02±1.5 % vs. 9.1±1.2 %, respectively; p=0.0001).

Hafiz QM et al. found that diabetics typically ranged in age from 41 to 60, with a mean age of 48.9 ± 9.86 years. The non-diabetic cohort had an average age of 47.9 ± 9.16 years, featuring a 70% male preponderance in group I and 61.5% in group II, and 30% females in group I and 38.5% in group II. Additionally, 40% of Group I had positive H. pylori IgG, but 64.1% of Group II did, indicating a significant difference (P < 0.05). In DM with H. pylori, FBS and PPBS levels were 192±60.3 and 318±78.4, respectively.

Henceforth during our research we have found a positive association between the occurrence of profile H. Pylori in type 2 DM patients. Furthermore, studies showed be conducted in future to provide proper prevention, management and treatment aspect for the same. This study found a substantial prevalence (45.3%) of H. pylori infection among T2DM patients, suggesting a possible association. However, no statistically significant correlation was found between glycemic control markers (HbA1c, FBS, PPBS) and H. pylori infection status. While certain gastrointestinal symptoms were more common in infected individuals, definitive clinical implications remain inconclusive. Further large-scale, longitudinal studies are warranted to better define this association, understand potential pathophysiological links, and assess whether targeted eradication of H. pylori could improve diabetic outcomes or symptom burden.

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