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BMJ Open May 2024Exercise has been used to reverse dysglycaemic states in patients with pre-diabetes. Systematic reviews show that exercise is an effective way to reduce the incidence of...
Comparative efficacy and acceptability of different exercise patterns for reducing cardiovascular events in pre-diabetes: protocol for a systematic review and network meta-analysis of randomised controlled trials.
INTRODUCTION
Exercise has been used to reverse dysglycaemic states in patients with pre-diabetes. Systematic reviews show that exercise is an effective way to reduce the incidence of diabetes, but there is conflicting evidence for reducing the occurrence of cardiovascular events. Therefore, we present a systematic review and network meta-analysis protocol designed to compare the effectiveness of different forms of exercise in reducing cardiovascular events and their tolerability in different populations.
METHODS AND ANALYSIS
We will include all randomised controlled trials and compare one exercise intervention to another. We will compare the following exercise patterns: standard endurance training, strength training, high-intensity interval training, mind-body exercise, and mixed strength and aerobic training. The primary outcomes are the occurrence of major cardiovascular events and the rate of patient attrition during the intervention. We will search major English and Chinese databases as well as trial registry websites for published and unpublished studies. All reference selection and data extraction will be conducted by at least two independent reviewers. We will conduct a random effects model to combine effect sizes and use the surface under the cumulative ranking curve and the mean ranks to rank the effectiveness of interventions. All data will be fitted at WinBUGS in a Bayesian framework and correlation graphs will be plotted using StataSE 14. We will also use the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework to evaluate the quality of evidence for the study results.
ETHICS AND DISSEMINATION
This study does not involve a population-based intervention, and therefore, does not require ethical approval. We will publish the findings of this systematic review in a peer-reviewed scientific journal, and the dataset will be made available free of charge. The completed review will be disseminated electronically in print and on social media, where appropriate.
PROSPERO REGISTRATION NUMBER
CRD42023422737.
Topics: Humans; Systematic Reviews as Topic; Randomized Controlled Trials as Topic; Network Meta-Analysis; Cardiovascular Diseases; Prediabetic State; Research Design; Exercise Therapy; Exercise; Resistance Training
PubMed: 38719281
DOI: 10.1136/bmjopen-2023-075783 -
Journal of Diabetes Research 2024Diabetes is considered a public health problem worldwide, fostered by population growth, an increase in the overall quality of life, changes in dietary patterns,... (Review)
Review
Diabetes is considered a public health problem worldwide, fostered by population growth, an increase in the overall quality of life, changes in dietary patterns, modifications in lifestyle habits, and the natural process of getting older. To properly control diabetes, the transtheoretical model (TTM) may be useful. This scoping review is aimed at identifying TTM interventions for diabetes. The study followed Arksey and O'Malley's six steps in conducting the scoping review. Four main databases (PubMed, Central, JSTOR, and ScienceDirect), Google Scholar, Google, and a reference list of identified articles were searched for literature. The study included peer-reviewed articles published online from 2000 to 2023 and published in the English language. At the end of the search, 3,514 entries were found in the four main databases, and 23 records were identified through Google, Google Scholar searches, and reference lists. After a thorough screening, 22 records were used for this review. The study found that the primary interventions based on the TTM for managing diabetes and prediabetes were educational materials to promote physical activity among diabetes and prediabetes individuals, health education, exercise, motivational interviews, self-tracking, and dietary changes. Further interventions on diabetes and prediabetes management could adopt the identified transtheoretical interventions to improve the health of their patients.
Topics: Humans; Prediabetic State; Exercise; Diabetes Mellitus; Life Style; Quality of Life; Health Behavior
PubMed: 38712311
DOI: 10.1155/2024/2935795 -
Journal of Inflammation Research 2024Type 2 diabetes mellitus (DM) is a recognized independent risk factor for both chronic coronary syndrome (CCS) and its complication, acute coronary syndrome (ACS)....
Correlations Between Acute Coronary Syndrome and Novel Inflammatory Markers (Systemic Immune-Inflammation Index, Systemic Inflammation Response Index, and Aggregate Index of Systemic Inflammation) in Patients with and without Diabetes or Prediabetes.
PURPOSE
Type 2 diabetes mellitus (DM) is a recognized independent risk factor for both chronic coronary syndrome (CCS) and its complication, acute coronary syndrome (ACS). Patients with DM and prediabetes (preDM) face an increased ACS risk. Inflammation plays a significant role in the pathogenesis of both CCS and ACS. This study delves into novel inflammatory markers, such as the systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), and aggregate index of systemic inflammation (AISI, also known as SIIRI or PIV), to explore their relationship with ACS and CCS in patients that have been or have not been diagnosed with DM or preDM.
PATIENTS AND METHODS
This study included data of 493 patients with chest pain undergoing coronary angiography. They were categorized into four groups: 1) without DM/preDM and with CCS; 2) with both DM/preDM and CCS; 3) without DM/preDM and with ACS, 4) with both DM/preDM and ACS. Standard methods of statistical analysis were used to reveal possible differences between groups and to find the most influential ACS risk factors in groups with DM/preDM and without DM/preDM.
RESULTS
The analysis showed no significant differences in SII, SIRI, or AISI between the respective patient groups. A logistic regression analysis generated a model incorporating SII, high-density lipoprotein, and low-density lipoprotein levels as the influential ACS risk factors for patients with DM/preDM. The model demonstrated 71.0% accuracy, 37.0% sensitivity, and 89.4% specificity.
CONCLUSION
The findings suggest that the aforementioned inflammatory markers may have potential for distinguishing DM/preDM patients at higher risk of ACS at a low financial cost. However, further comprehensive and well-designed research is required to validate their clinical utility.
PubMed: 38707954
DOI: 10.2147/JIR.S454117 -
Kidney International Reports May 2024The pathogenesis of renal disease in obesity and metabolic syndrome (MS) is mostly unknown. This is in part because of the limited information about renal morphological...
INTRODUCTION
The pathogenesis of renal disease in obesity and metabolic syndrome (MS) is mostly unknown. This is in part because of the limited information about renal morphological changes in these conditions. We evaluated renal histology in subjects with MS and those without MS, who are participants in the European Nephrectomy Biobank (ENBiBA) project.
METHODS
MS was defined with at least 3 of the following criteria: (i) body mass index (BMI) ≥27 kg/m; (ii) prediabetes: fasting glucose of 100-125 mg/dl or HbA1c >5.7%; (iii) systolic or diastolic blood pressure >140/90 mm Hg or the use of medications; and (iv) triglycerides >150 mg/dl or high-density lipoprotein cholesterol <40 (in men) or 50 mg/dl (in women). The absence of these criteria defined patients without MS. Exclusion criteria were diabetes or known causes of renal disease.
RESULTS
A total of 157 cases were evaluated: 49 without and 108 with MS. Those with MS were older (54 ± 16 vs. 66 ± 11, < 0.0001), had more prevalent chronic kidney disease (CKD, estimated glomerular filtration rate [eGFR] <60 ml/min): 24% (23%) versus 4% (8%) ( = 0.02), and had higher albumin-to-creatinine ratio (10 [4-68] vs. 4.45 [0-27], = 0.05) than those without MS. Global sclerosis (3% [1-7] vs. 7% [3-13], < 0.0001), nodular sclerosis, mesangial expansion, glomerulomegaly; moderate + severe hyalinosis, and arteriosclerosis were more frequent in those with MS than in those without (88 [82] vs. 29 [59]; 83 [77] vs. 30 [61]; < 0.05). These vascular changes were independent of differences in age.
CONCLUSION
In MS, ischemic renal disease may play a role in renal disease. In addition, some patients may develop lesions compatible with diabetic nephropathy such as increased mesangial expansion and nodular sclerosis. Further analyses are needed to study the consequences of the pandemic of obesity on renal health.
PubMed: 38707823
DOI: 10.1016/j.ekir.2024.02.1403 -
JAMA Network Open May 2024Polycystic ovary syndrome (PCOS), characterized by irregular menstrual cycles and hyperandrogenism, is a common ovulatory disorder. Having an irregular cycle is a...
IMPORTANCE
Polycystic ovary syndrome (PCOS), characterized by irregular menstrual cycles and hyperandrogenism, is a common ovulatory disorder. Having an irregular cycle is a potential marker for cardiometabolic conditions, but data are limited on whether the associations differ by PCOS status or potential interventions.
OBJECTIVE
To evaluate the association of PCOS, time to regularity since menarche (adolescence), and irregular cycles (adulthood) with cardiometabolic conditions.
DESIGN, SETTING, AND PARTICIPANTS
This cross-sectional study used a large, US-based digital cohort of users of the Apple Research application on their iPhone. Eligibility criteria were having ever menstruated, living in the US, being at age of consent of at least 18 years (or 19 years in Alabama and Nebraska or 21 years in Puerto Rico), and being able to communicate in English. Participants were enrolled between November 14, 2019, and December 13, 2022, and completed relevant surveys.
EXPOSURES
Self-reported PCOS diagnosis, prolonged time to regularity (not spontaneously establishing regularity within 5 years of menarche), and irregular cycles.
MAIN OUTCOMES AND MEASURES
The primary outcome was self-reported cardiometabolic conditions, including obesity, prediabetes, type 1 and 2 diabetes, high cholesterol, hypertension, metabolic syndrome, arrhythmia, congestive heart failure, coronary artery disease, heart attack, heart valve disease, stroke, transient ischemic attack (TIA), deep vein thrombosis, and pulmonary embolism measured using descriptive statistics and logistic regression to estimate prevalence odds ratios (PORs) and 95% CIs. Effect modification by lifestyle factors was also estimated.
RESULTS
The study sample (N = 60 789) had a mean (SD) age of 34.5 (11.1) years, with 12.3% having PCOS and 26.3% having prolonged time to regularity. Among a subset of 25 399 participants who completed the hormonal symptoms survey, 25.6% reported irregular cycles. In covariate-adjusted logistic regression models, PCOS was associated with a higher prevalence of all metabolic and several cardiovascular conditions, eg, arrhythmia (POR, 1.37; 95% CI, 1.20-1.55), coronary artery disease (POR, 2.92; 95% CI, 1.95-4.29), heart attack (POR, 1.79; 95% CI, 1.23-2.54), and stroke (POR, 1.66; 95% CI, 1.21-2.24). Among participants without PCOS, prolonged time to regularity was associated with type 2 diabetes (POR, 1.24; 95% CI, 1.05-1.46), hypertension (POR, 1.09; 95% CI, 1.01-1.19), arrhythmia (POR, 1.20; 95% CI, 1.06-1.35), and TIA (POR, 1.33; 95% CI, 1.01-1.73), and having irregular cycles was associated with type 2 diabetes (POR, 1.36; 95% CI, 1.08-1.69), high cholesterol (POR, 1.17; 95% CI, 1.05-1.30), arrhythmia (POR, 1.21; 95% CI, 1.02-1.43), and TIA (POR, 1.56; 95% CI, 1.06-2.26). Some of these associations were modified by high vs low body mass index or low vs high physical activity.
CONCLUSIONS AND RELEVANCE
These findings suggest that PCOS and irregular cycles may be independent markers for cardiometabolic conditions. Early screening and intervention among individuals with irregular menstrual cycles may be beneficial.
Topics: Humans; Female; Polycystic Ovary Syndrome; Cross-Sectional Studies; Adult; Menstruation Disturbances; United States; Cardiovascular Diseases; Young Adult; Cohort Studies; Middle Aged; Obesity; Adolescent; Alabama
PubMed: 38700861
DOI: 10.1001/jamanetworkopen.2024.9657 -
Cureus Apr 2024Neuroendocrine tumors (NETs) are rare. When present, they often produce serotonin and are called carcinoids. Serotonin-secreting NETs can present with or without...
Neuroendocrine tumors (NETs) are rare. When present, they often produce serotonin and are called carcinoids. Serotonin-secreting NETs can present with or without carcinoid syndrome. Although the idea of serotonin-secreting NETs potentially altering glucose metabolism is not new, data around this issue has been scarce, with only a few limited studies and case reports. We present a case where a female patient's prediabetic hemoglobin A1C levels normalized after removing serotonin-secreting NET. Before removal, the patient had locally metastatic carcinoid and serotonin-related intractable diarrhea but did not exhibit any other sign of carcinoid syndrome, including flushing, which is considered a hallmark. Therefore, in suggestive clinical contexts, this case points to the possibility of impaired glucose tolerance being an early clinical sign of carcinoid that could aid in serotonin-secreting NET diagnosis before it manifests as overt carcinoid syndrome.
PubMed: 38694675
DOI: 10.7759/cureus.57376 -
International Journal of Circumpolar... Dec 2024Pre-diabetes (pre-DM) is a strong predictor of diabetes (DM) over time. This study investigated how much of the recent increase in pre-DM identified among Alaska Native...
Evidence-based screening, clinical care and health education recommendations for Alaska Native peoples with prediabetes living in southcentral Alaska: findings from the Alaska EARTH follow-up study.
Pre-diabetes (pre-DM) is a strong predictor of diabetes (DM) over time. This study investigated how much of the recent increase in pre-DM identified among Alaska Native (AN) peoples living in urban southcentral Alaska may be due to changes in diagnostic methods. We used clinical and demographic data collected at baseline between 2004 and 2006 and at follow-up collected between 2015 and 2017 from the urban southcentral Alaska Education and Research Towards Health (EARTH) cohort. We used descriptive statistics and logistic regression to explore differences in demographic and clinical variables among the identified pre-DM groups. Of 388 participants in the follow-up study, 243 had A1c levels indicating pre-DM with only 20 demonstrating pre-DM also by fasting blood glucose (FBG). Current smoking was the sole predictor for pre-DM by A1c alone while abdominal obesity and elevated FBG-predicted pre-DM by A1c+FBG. No participants had an elevated FBG without an A1c elevation. A substantial portion of the rise in pre-DM found among urban southcentral AN peoples in the EARTH follow-up study was due to the addition of A1c testing. Pre-DM by A1c alone should be used to motivate behavioural changes that address modifiable risk factors, including smoking cessation, physical activity and weight management.
Topics: Humans; Alaska; Male; Prediabetic State; Female; Alaska Natives; Middle Aged; Adult; Follow-Up Studies; Health Education; Glycated Hemoglobin; Blood Glucose; Mass Screening; Aged; Smoking; Risk Factors
PubMed: 38691019
DOI: 10.1080/22423982.2024.2343143 -
Clinical Therapeutics May 2024Glucophage (Merck Healthcare KGaA, Darmstadt, Germany) is the originator brand of metformin hydrochloride, an oral antidiabetic drug. Metformin is recommended in... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
Glucophage (Merck Healthcare KGaA, Darmstadt, Germany) is the originator brand of metformin hydrochloride, an oral antidiabetic drug. Metformin is recommended in guidelines as first-line treatment of type 2 diabetes mellitus and increasingly in related insulin-resistant conditions, such as prediabetes and polycystic ovary syndrome. The GelShield sustained-release formulation tablet of Glucophage has been improved from the historic version marketed in 2000. Bioequivalence has been demonstrated stepwise along this evolution; however, a head-to-head evaluation between the initial and the current version is missing. This analysis aims to close this gap and to determine bioequivalence between related originator GelShield sustained-release formulations of metformin, Glucophage (GXR 500 mg), from Europe and the United States.
METHODS
Data from seven randomized crossover bioequivalence studies in 361 healthy participants of Asian and non-Asian ethnicity from Europe, the United States, and Asia were considered. All evaluated a single oral dose of 500 mg of the test and reference formulation in healthy male and female participants in fed and fasted state. Bioequivalence was evaluated by means of a combined bridging analysis of available data on the current round tablet from Europe (rGXR EU) and the historic oblong tablet from the United States (oGXR US) in healthy Asian and non-Asian participants under fed and fasting conditions. Bioequivalence between the two formulations was assessed statistically with a mixed effects model for AUC, C, and AUC.
FINDINGS
In all studies, bioequivalence between the respective test and reference formulations of GXR was shown. Statistical analysis of pooled pharmacokinetic data of 2 (primary pooling set) or 3 studies (secondary pooling set) demonstrated bioequivalence between rGXR EU and oGXR US via bridging with oGXR EU. The 90% CI for the geometric mean ratio of all pharmacokinetic parameters was within the bioequivalence range of 0.80 to 1.25. In the primary pooling set, geometric least squares mean ratios in the fed group ranged from 0.9931 (90% CI, 0.9151-1.0778) for AUC to 1.1344 (90% CI, 1.0711-1.2014) for C; results in the fasted group were similar. The secondary pooling set, which added a study in Asians, confirmed these findings.
IMPLICATIONS
Bioequivalence was determined between sustained-release formulations of Glucophage from Europe and the United States under fasted and fed conditions in healthy men and women, including different ethnicities. The efficacy and safety of Glucophage XR can be claimed along the evolution from oGXR US, via oGXR EU to rGXR EU, and in several ethnicities and production sites.
Topics: Therapeutic Equivalency; Metformin; Humans; Delayed-Action Preparations; Hypoglycemic Agents; Female; Male; Cross-Over Studies; Adult; United States; Tablets; Europe; Young Adult; Area Under Curve; Middle Aged; Administration, Oral; Fasting
PubMed: 38688745
DOI: 10.1016/j.clinthera.2024.03.011 -
Cardiovascular Diabetology Apr 2024The GLP-1 receptor agonist liraglutide is used to treat hyperglycemia in type 2 diabetes but is also known to induce weight loss, preserve the beta cell and reduce... (Comparative Study)
Comparative Study
BACKGROUND
The GLP-1 receptor agonist liraglutide is used to treat hyperglycemia in type 2 diabetes but is also known to induce weight loss, preserve the beta cell and reduce cardiovascular risk. The mechanisms underlying these effects are however still not completely known. Herein we explore the effect of liraglutide on markers of immune cell activity in a population of obese individuals with prediabetes or newly diagnosed type 2 diabetes mellitus.
METHOD
Plasma levels of the monocyte/macrophage markers, soluble (s)CD163 and sCD14, the neutrophil markers myeloperoxidase (MPO) and neutrophil gelatinase-associated lipocalin (NGAL),the T-cell markers sCD25 and T-cell immunoglobulin mucin domain-3 (sTIM-3) and the inflammatory marker TNF superfamily (TNFSF) member 14 (LIGHT/TNFSF14) were measured by enzyme-linked immunosorbent assays in obese individuals with prediabetes or diabetes diagnosed within the last 12 months, prior to and after comparable weight loss achieved with lifestyle changes (n = 20) or liraglutide treatment (n = 20), and in healthy subjects (n = 13).
RESULTS
At baseline, plasma levels of the macrophage marker sCD163, and the inflammatory marker LIGHT were higher in cases as compared to controls. Plasma levels of sCD14, NGAL, sTIM-3 and sCD25 did not differ at baseline between patients and controls. After weight reduction following lifestyle intervention or liraglutide treatment, sCD163 decreased significantly in the liraglutide group vs. lifestyle (between-group difference p = 0.023, adjusted for visceral adipose tissue and triglycerides basal values). MPO and LIGHT decreased significantly only in the liraglutide group (between group difference not significant). Plasma levels of MPO and in particular sCD163 correlated with markers of metabolic dysfunction and inflammation. After weight loss, only sCD163 showed a trend for decreased levels during OGTT, both in the whole cohort as in those of liraglutide vs lifestyle group.
CONCLUSION
Weight loss following treatment with liraglutide was associated with reduced circulating levels of sCD163 when compared to the same extent of weight loss after lifestyle changes. This might contribute to reduced cardiometabolic risk in individuals receiving treatment with liraglutide.
Topics: Humans; Liraglutide; Diabetes Mellitus, Type 2; Weight Loss; Male; Middle Aged; Female; Obesity; Biomarkers; Antigens, Differentiation, Myelomonocytic; Prediabetic State; Receptors, Cell Surface; Treatment Outcome; Antigens, CD; Risk Reduction Behavior; Incretins; Adult; Case-Control Studies; Time Factors; Down-Regulation; Hypoglycemic Agents; Aged
PubMed: 38685051
DOI: 10.1186/s12933-024-02237-8 -
Scientific Reports Apr 2024Lifestyle modifications, metformin, and linagliptin reduce the incidence of type 2 diabetes (T2D) in people with prediabetes. The gut microbiota (GM) may enhance such...
Lifestyle modifications, metformin, and linagliptin reduce the incidence of type 2 diabetes (T2D) in people with prediabetes. The gut microbiota (GM) may enhance such interventions' efficacy. We determined the effect of linagliptin/metformin (LM) vs metformin (M) on GM composition and its relationship to insulin sensitivity (IS) and pancreatic β-cell function (Pβf) in patients with prediabetes. A cross-sectional study was conducted at different times: basal, six, and twelve months in 167 Mexican adults with prediabetes. These treatments increased the abundance of GM SCFA-producing bacteria M (Fusicatenibacter and Blautia) and LM (Roseburia, Bifidobacterium, and [Eubacterium] hallii group). We performed a mediation analysis with structural equation models (SEM). In conclusion, M and LM therapies improve insulin sensitivity and Pβf in prediabetics. GM is partially associated with these improvements since the SEM models suggest a weak association between specific bacterial genera and improvements in IS and Pβf.
Topics: Humans; Metformin; Gastrointestinal Microbiome; Prediabetic State; Male; Female; Middle Aged; Cross-Sectional Studies; Linagliptin; Hypoglycemic Agents; Diabetes Mellitus, Type 2; Insulin Resistance; Adult; Insulin-Secreting Cells; Aged
PubMed: 38678119
DOI: 10.1038/s41598-024-60081-y