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Water-soluble polyphenol-rich clove extract lowers pre- and post-prandial blood glucose levels in healthy and prediabetic volunteers: an open label pilot study.
Mohan, R, Jose, S, Mulakkal, J, Karpinsky-Semper, D, Swick, AG, Krishnakumar, IM
BMC complementary and alternative medicine. 2019;(1):99
Abstract
BACKGROUND/OBJECTIVES Type 2 diabetes (T2D) is a global pandemic, and contributes significantly to the increasing incidence of conditions such as cardiovascular disease (CVD). Postprandial plasma glucose measured 2-h after the start of a meal is a good indicator of the overall status of glucose homeostasis. Clove (Syzygium aromaticum L.) and its essential oils (eugenol and acetyl eugenol) have been shown in preclinical studies to modulate pathways involved in glucose homeostasis. In addition, a water-soluble polyphenolic extract of unopened clove buds was recently shown to benefit liver function and redox status. Therefore, we conducted an open-label pilot study to test whether this polyphenolic clove extract (PCE) could influence glucose metabolism. METHODS We evaluated the effect of PCE supplementation (250 mg once daily for 30 days) on preprandial glucose levels and 2-h postprandial glucose levels in 13 otherwise healthy volunteers who were stratified into two groups according to their initial preprandial glucose levels: Group I (n = 7) ≤100 mg/dL, Group II (n = 6) - between 101 and 125 mg/dL. In an effort to elucidate the molecular mechanisms of PCE action, we tested in vitro the effects of PCE on glucose uptake, hepatocyte glucose production, and carbohydrate hydrolyzing enzymes. RESULTS At day 12 of supplementation, we observed statistically significant reductions in mean postprandial glucose levels in both groups [(Group I: Initial - Day 12 PPG = 13.29 mg/dL, 95% CI: 3.329-23.24) (Group II: Initial - Day 12 PPG = 16.67 mg/dL, 95% CI: 4.687-28.65, P = 0.0159)], which continued through study completion at day 30. PCE supplementation significantly decreased mean preprandial glucose levels only in Group II at Days 24 (Initial - Day 24 = 13.00 mg/dL, 95% CI: 1.407-24.59, P = 0.0345) and 30 (Initial - Day 30 = 13.67 mg/dL, 95% CI: 5.766-21.57, P = 0.0067). In cell-based assays, PCE enhanced glucose uptake in L6 myocytes and inhibited hepatocyte glucose production HepG2 cells. In cell-free assays, PCE inhibited α-amylase activity and α-glucosidase activity. CONCLUSIONS These findings underscore the therapeutic utility of PCE for maintaining healthy glucose metabolism and warrant further larger-scale clinical trials. TRIAL REGISTRATION This trial was retrospectively registered in the ISRCTN registry on September 29, 2018 ( ISRCTN15680985 ).
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Use of an online personal health record's Track Health function to promote positive lifestyle behaviors in Veterans with prediabetes.
Sharit, J, Idrees, T, Andrade, AD, Anam, R, Karanam, C, Valencia, W, Florez, H, Ruiz, JG
Journal of health psychology. 2018;(5):681-690
Abstract
This pilot 3-month clinical trial investigated the feasibility, effectiveness, and acceptability of using the Track Health function of the Veterans Health Administration's personal health record for eliciting a more positive physical activity and dietary intake lifestyle in a sample of 38 overweight and obese Veterans with prediabetes. Comparisons between baseline and 3 months post-intervention indicated significant improvements in weight, physical activity, abdominal circumference, and blood pressure. Use of a personal health record that users can identify with and find usable and useful coupled with instruction targeting critical functionalities could potentially promote healthy behavioral lifestyle changes.
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Study of Saroglitazar in Treatment Of Pre-diabetes with Dyslipidemia: STOP-D.
Bhosle, D, Bhosle, V, Bobde, J, Bhagat, A, Shaikh, H, Kadam, R
The Journal of the Association of Physicians of India. 2018;(3):14-7
Abstract
OBJECTIVES Patients with prediabetes are not only at increased risk of progression to type 2 diabetes, but they are also at high risk of developing cardiovascular risk compared to normoglycemic people. Further, prediabetes is also often associated with abnormal lipid levels (dyslipidemia). We therefore aimed to evaluate the effect of Saroglitazar in patients with prediabetes and dyslipidemia. METHODS This was a prospective, single centre, single arm study involving patients with pre-diabetes and dyslipidemia. Subjects with baseline HbA1c 5.7-6.4% and dyslipidemia (Total cholesterol > 200mg/dl, LDL-C > 130 mg/dl, triglycerides > 150 mg/dl and HDL< 40 mg/dl) were enrolled in this study. Subjects with on-going medications affecting blood glucose or lipids were excluded from the study. Saroglitazar 4mg once daily was administered for a period of 24 weeks. The primary outcome was change in serum triglycerides and secondary outcome parameters included changes in other lipid parameters and HbA1c levels at 24 weeks follow-up. RESULTS Forty patients with prediabetes and dyslipidemia were enrolled in the study. At 24 weeks follow-up, serum triglycerides was significantly reduced from 348 ± 86.98 mg/dl to 216.4 ± 72.34 mg/dl (P <0.0001). HbA1c was significantly reduced from 6.3 ± 0.16 % to 5.5 ± 0.30 % after 24 weeks of Saroglitazar therapy (P<0.0001). There were significant improvements observed in other lipid parameters at 24 weeks follow-up period. Saroglitazar was found to be safe and well tolerated, no serious adverse event reported during entire study period. CONCLUSION Saroglitazar is safe and effective in prediabetes with dyslipidemia by exerting its dual lipid lowering and glycemic actions.
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Vitamin D and Incidence of Prediabetes or Type 2 Diabetes: A Four-Year Follow-Up Community-Based Study.
Gao, Y, Zheng, T, Ran, X, Ren, Y, Chen, T, Zhong, L, Yan, D, Yan, F, Wu, Q, Tian, H
Disease markers. 2018;:1926308
Abstract
AIM: To examine whether the baseline 25-hydroxyvitamin D [25(OH)D] level was predictive of the onset of prediabetes or type 2 diabetes (T2DM) in the Chinese population. METHODS This was a 4-year follow-up study that was conducted in the Chengdu region of China as part of the China National Diabetes and Metabolic Disorders Study. The study included 490 participants that were free of prediabetes and type 2 diabetes mellitus (T2DM) at baseline and had complete data by follow-up examinations. Glucose, insulin, and 25(OH)D levels were measured at baseline and at 4 years later. Prediabetes and T2DM were defined by results obtained from an oral glucose tolerance test. RESULTS Over a 4-year follow-up, 95 (48.5‰) developed prediabetes and 31 (15.8‰) individuals developed diabetes. Low 25(OH)D status was significantly associated with the risk of developing prediabetes [OR 3.01 (95% CI: 1.50-6.06), P = 0.002] and T2DM [OR 5.61 (95% CI: 1.73-18.27), P = 0.004] after adjustment for multiple potential confounders. In a multiple linear regression analysis, low baseline levels of 25(OH)D were an independent predictor of increased insulin resistance over a 4-year period (P < 0.05). CONCLUSIONS The current prospective study suggests that low 25(OH)D levels might have contributed to the incidence of prediabetes or T2DM in Chinese individuals. This trial is registered with TR-CCH-ChiCTR-OCS-09000361.
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Association Between Metabolic Syndrome Components and Polyneuropathy in an Obese Population.
Callaghan, BC, Xia, R, Reynolds, E, Banerjee, M, Rothberg, AE, Burant, CF, Villegas-Umana, E, Pop-Busui, R, Feldman, EL
JAMA neurology. 2016;(12):1468-1476
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Abstract
IMPORTANCE Past studies have shown an association between metabolic syndrome and polyneuropathy, but the precise components that drive this association remain unclear. OBJECTIVES To determine the prevalence of polyneuropathy stratified by glycemic status in well-characterized obese and lean participants and investigate the association of specific components of metabolic syndrome with polyneuropathy. DESIGN, SETTING, AND PARTICIPANTS We performed a cross-sectional, observational study from November 1, 2010, to December 31, 2014, in obese participants (body mass index [calculated as weight in kilograms divided by height in meters squared] of 35 or more with no comorbid conditions or 32 or more with at least 1 comorbid condition) from a weight management program and lean controls from a research website. The prevalence of neuropathy, stratified by glycemic status, was determined, and a Mantel-Haenszel χ2 test was used to investigate for a trend. Logistic regression was used to model the primary outcome of polyneuropathy as a function of the components of metabolic syndrome after adjusting for demographic factors. Participants also completed quantitative sudomotor axon reflex testing, quantitative sensory testing, the neuropathy-specific Quality of Life in Neurological Disorders instrument, and the short-form McGill Pain Questionnaire. EXPOSURES Components of metabolic syndrome (as defined by the National Cholesterol Education Program Adult Treatment Panel III), including glycemic status (as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus). MAIN OUTCOMES AND MEASURES Toronto consensus definition of probable polyneuropathy. Secondary outcomes included intraepidermal nerve fiber density and nerve conduction study parameters. RESULTS We enrolled 102 obese participants (mean [SD] age, 52.9 [10.2] years; 48 men and 54 women; 45 with normoglycemia [44.1%], 31 with prediabetes [30.4%], and 26 with type 2 diabetes [25.5%]) and 53 lean controls (mean [SD] age, 48.5 [9.9] years; 16 men and 37 women). The prevalence of polyneuropathy was 3.8% in lean controls (n = 2), 11.1% in the obese participants with normoglycemia (n = 5), 29% in the obese participants with prediabetes (n = 9), and 34.6% in the obese participants with diabetes (n = 9) (P < .01 for trend). Age (odds ratio, 1.09; 95% CI, 1.02-1.16), diabetes (odds ratio, 4.90; 95% CI, 1.06-22.63), and waist circumference (odds ratio, 1.24; 95% CI, 1.00-1.55) were significantly associated with neuropathy in multivariable models. Prediabetes (odds ratio, 3.82; 95% CI, 0.95-15.41) was not significantly associated with neuropathy. CONCLUSIONS AND RELEVANCE The prevalence of polyneuropathy is high in obese individuals, even those with normoglycemia. Diabetes, prediabetes, and obesity are the likely metabolic drivers of this neuropathy. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02689661.
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Dietary intake modification in response to a participation in a resistance training program for sedentary older adults with prediabetes: findings from the Resist Diabetes study.
Halliday, TM, Davy, BM, Clark, AG, Baugh, ME, Hedrick, VE, Marinik, EL, Flack, KD, Savla, J, Winett, S, Winett, RA
Eating behaviors. 2014;(3):379-82
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Engagement in one type of health behavior change may exert a "spillover" effect resulting in other behavior changes. Few studies have examined dietary intake following prolonged training, and none have evaluated spontaneous dietary changes beyond alterations in energy or macronutrient intake following initiation of strength/resistance training (RT). The purpose of this observational investigation was to determine if spontaneous dietary intake modifications occur in response to initiation of an RT program, among older adults. Previously sedentary adults with prediabetes (n=134, age=59±1 years) were enrolled in a supervised 12-week RT program. Participants were not given dietary advice or encouraged to change eating behaviors. Three non-consecutive 24-hour dietary recalls were collected at baseline and after 12 weeks of RT. Reductions in intake of energy (1914±40 kcal vs. 1834±427 kcal, p=0.010), carbohydrate (211.6±4.9 g vs. 201.7±5.2 g, p=0.015), total sugar (87.4±2.7 g vs. 81.5±3.1 g, p=0.030), glycemic load (113.4±3.0 vs. 108.1±3.2, p=0.031), fruits and vegetables (4.6±0.2 servings vs. 4.1±0.2 servings, p=0.018), and sweets and desserts (1.1±0.07 servings vs. 0.89±0.07 servings, p=0.023) were detected over time. No changes in other dietary intake variables were observed. Mode of exercise and disease state may be important factors in determining whether dietary modifications occur with exercise initiation, among previously sedentary adults. Successful initiation of RT may represent an opportunity for health care professionals to promote beneficial changes in dietary habits, among older adults with prediabetes.
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A novel fasting blood test for insulin resistance and prediabetes.
Cobb, J, Gall, W, Adam, KP, Nakhle, P, Button, E, Hathorn, J, Lawton, K, Milburn, M, Perichon, R, Mitchell, M, et al
Journal of diabetes science and technology. 2013;(1):100-10
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BACKGROUND Insulin resistance (IR) can precede the dysglycemic states of prediabetes and type 2 diabetes mellitus (T2DM) by a number of years and is an early marker of risk for metabolic and cardiovascular disease. There is an unmet need for a simple method to measure IR that can be used for routine screening, prospective study, risk assessment, and therapeutic monitoring. We have reported several metabolites whose fasting plasma levels correlated with insulin sensitivity. These metabolites were used in the development of a novel test for IR and prediabetes. METHODS Data from the Relationship between Insulin Sensitivity and Cardiovascular Disease Study were used in an iterative process of algorithm development to define the best combination of metabolites for predicting the M value derived from the hyperinsulinemic euglycemic clamp, the gold standard measure of IR. Subjects were divided into a training set and a test set for algorithm development and validation. The resulting calculated M score, M(Q), was utilized to predict IR and the risk of progressing from normal glucose tolerance to impaired glucose tolerance (IGT) over a 3 year period. RESULTS M(Q) correlated with actual M values, with an r value of 0.66. In addition, the test detects IR and predicts 3 year IGT progression with areas under the curve of 0.79 and 0.70, respectively, outperforming other simple measures such as fasting insulin, fasting glucose, homeostatic model assessment of IR, or body mass index. CONCLUSIONS The result, Quantose(TM), is a simple test for IR based on a single fasting blood sample and may have value as an early indicator of risk for the development of prediabetes and T2DM.
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A community-based diabetes prevention program: evaluation of the group lifestyle balance program delivered by diabetes educators.
Kramer, MK, McWilliams, JR, Chen, HY, Siminerio, LM
The Diabetes educator. 2011;(5):659-68
Abstract
PURPOSE With growing numbers of people at risk for diabetes and cardiovascular disease, diabetes educators report increasing referrals for intervention in prevention of these conditions. Diabetes educators have expertise in diabetes self-management education; however, they are generally not prepared for delivery of chronic disease primary prevention. The purpose of this project was to determine if individuals at risk for diabetes who participate in an intervention delivered by trained diabetes educators in existing diabetes self-management education community-based programs can reduce risk factors for diabetes and cardiovascular disease. METHODS Diabetes educators in 3 outpatient-hospital programs (urban, suburban, and rural) received training and support for implementation of the Group Lifestyle Balance program, an adaptation of the Diabetes Prevention Program lifestyle intervention, from the Diabetes Prevention Support Center of the University of Pittsburgh. Adults with prediabetes and/or the metabolic syndrome were eligible to enroll in the program with physician referral. With use of existing diabetes educator networks, recruitment was completed via on-site physician in-services, informative letters, and e-mail contact as well as participant-directed newspaper advertisement. RESULTS Eighty-one participants enrolled in the study (71 women, 10 men). Mean overall weight loss was 11.3 lb (5.1%, P < .001); in addition, significant decreases were noted in fasting plasma glucose, low-density lipoprotein cholesterol, triglycerides, and blood pressure. CONCLUSIONS These results suggest that the Group Lifestyle Balance program delivered by diabetes educators was successful in reducing risk for diabetes and cardiovascular disease in high-risk individuals. Furthermore, diabetes educators, already integrated within the existing health care system, provide yet another resource for delivery of primary prevention programs in the community.
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Role of hypoadiponectinemia in the metabolic syndrome and its association with post-glucose challenge hyper-free fatty acidemia: a study in prediabetic Japanese males.
Mori, Y, Hoshino, K, Yokota, K, Itoh, Y, Tajima, N
Endocrine. 2006;(2):357-61
Abstract
We investigated the role of hypoadiponectinemia in the metabolic syndrome (MS), as well as its association with post-glucose challenge hyper-free fatty acidemia in the clinical setting. The study subjects comprised 177 corporate employees shown to have a fasting plasma glucose (FPG) level of 125 mg/dL or less in a 75 g OGTT in the corporation's healthcare center. When divided into those who met the Japanese criteria for the metabolic syndrome (MS group; n = 45) and those who did not (Non-MS group; n = 132), the MS group was shown to have significantly lower adiponectin levels than the Non-MS group, and tended to show higher high-sensitivity C-reactive protein (CRP) values than the Non-MS group, while not achieving statistical significance. The MS group showed higher baseline glucose levels; higher baseline, 30-, 60-, and 120-min post-challenge insulin levels; higher 30-, 60-, and 120-min post-challenge free fatty acid levels than the Non-MS group. Additionally, there was a significant, negative correlation between adiponectin levels, area under the free fatty acid curve, and area under the insulin curve at OGTT (r = -0.24, p < 0.01; r = -0.21, p < 0.01, respectively). When the patients were divided by adiponectin level into four groups to examine the number of risk factors for MS detected per patient and the incidence of MS, the lower the adiponectin level, the more risk factors were found per patient, with 68% of patients with an adiponectin level of less than 4 microg/mL found to have MS. In those with an adiponectin level of less than 4 microg/mL, BMI values, uric acid levels, HOMA-R values, and the number of risk factors for MS involved per patient were shown to be higher than in those with an adiponectin level of 4 microg/mL or greater. Furthermore, the following risk factors for MS were more frequently found in those with an adiponectin level of less than 4 microg/mL than in those with an adiponectin level of 4 microg/mL or greater: VFA > or = 100 cm2 (OR 12.8, p < 0.001); TG > or = 150 mg/dL (OR 3.2, p < 0.05); HDLC < 40 mg/dL (OR 1.9, p = 0.29); BP > or = 130/85 mmHg (OR 2.2, p = 0.15); and FPG > or = 110 mg/dL (OR 1.9, p = 0.29). Again, the incidence of MS (OR 7.6, p < 0.001) by the ATPIII criteria, as well as that by the Japanese criteria (OR 8.6, p < 0.001), was found to be higher in those with an adiponectin level of less than 4 microg/mL than in those with an adiponectin level of 4 microg/mL or greater. Our study results suggest that adiponectin is closely associated with the multiple risk factors that go to make up the MS, suggesting a role for hypoadiponectinemia as a surrogate marker for the MS and further appear to suggest that post-challenge hyper-free fatty acidemia may account in part for hypoadiponectinemia in the MS.