Influence of Cinnamon on Glycemic Control in Individuals With Prediabetes: A Randomized Controlled Trial

Abstract Context The identification of adjunct safe, durable, and cost-effective approaches to reduce the progression from prediabetes to type 2 diabetes (T2D) is a clinically relevant, unmet goal. It is unknown whether cinnamon’s glucose-lowering properties can be leveraged in individuals with prediabetes. Objective The objective of this work is to investigate the effects of cinnamon on measures of glucose homeostasis in prediabetes. Design, Setting, Participants, and Intervention This double-blind, placebo-controlled, clinical trial randomly assigned adult individuals meeting any criteria for prediabetes to receive cinnamon 500 mg or placebo thrice daily (n = 27/group). Participants were enrolled and followed at 2 academic centers for 12 weeks. Main Outcome Measures Primary outcome was the between-group difference in fasting plasma glucose (FPG) at 12 weeks from baseline. Secondary end points included the change in 2-hour PG of the oral glucose tolerance test (OGTT), and the change in the PG area under the curve (AUC) derived from the OGTT. Results From a similar baseline, FPG rose after 12 weeks with placebo but remained stable with cinnamon, leading to a mean between-group difference of 5 mg/dL (P < .05). When compared to the respective baseline, cinnamon, but not placebo, resulted in a significant decrease of the AUC PG (P < .001) and of the 2-hour PG of the OGTT (P < .05). There were no serious adverse events in either study group. Conclusions In individuals with prediabetes, 12 weeks of cinnamon supplementation improved FPG and glucose tolerance, with a favorable safety profile. Longer and larger studies should address cinnamon’s effects on the rate of progression from prediabetes to T2D.

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Baseline Characteristics of Participants in a Randomized Controlled Trial of Metformin for Frailty Prevention

Innovation in Aging ◽

10.1093/geroni/igaa057.428 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

pp. 130-131

Author(s):

Tiffany Cortes ◽

Nicolas Musi ◽

Chen-pin Wang ◽

Joel Michalek ◽

Sara Espinoza

Keyword(s):

Randomized Controlled Trial ◽

Glucose Tolerance ◽

Physical Performance ◽

Controlled Trial ◽

Tolerance Test ◽

Oral Glucose ◽

Double Blind ◽

Randomized Controlled ◽

Insulin Clamp ◽

And Function

Abstract We are conducting a double-blind, randomized controlled trial of metformin for frailty prevention. Participants are adults aged 65+ years with pre-diabetes assessed by 2-hour oral glucose tolerance test (OGTT). Those who are frail (Fried criteria) are excluded. Participants are randomized to metformin (maximum dose of 2,000 mg/day) vs. placebo and followed for 2 years. The primary outcome is frailty (category and score); secondary outcomes are physical performance and function (short physical performance battery, 6-minute walk, lower extremity strength), systemic and skeletal muscle tissue inflammation, muscle insulin signaling, insulin sensitivity (insulin clamp), glucose tolerance (OGTT), and body composition (dual-energy x-ray absorptiometry). Safety assessments occur every 3 months; frailty, systemic inflammation, and OGTT are assessed at baseline and every 6 months, and insulin clamp with muscle biopsies are assessed at baseline and every 12 months. To date, 85 subjects have been randomized; 120 completers are planned. Mean age is 72.8 ± 5.7 years, 55.3% are male, and 43.5% were Hispanic. Mean BMI is 30.2±5.8 kg/m2, waist circumference is 104.4 ±15.5 cm, fasting glucose is 102.3 ± 10.0 mg/dL, Hemoglobin A1c is 5.8 ±0.3, and glucose at 2 hours during OGTT is 167.3 ± 17.8 mg/dL. Metformin is being examined in this study as a potential therapeutic agent to prevent frailty in older adults with pre-diabetes. Findings from this trial may have future implications for the screening and potential treatment of pre-diabetes in older patients with metformin for the prevention of frailty.

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Effect of antenatal dietary myo-inositol supplementation on the incidence of gestational diabetes mellitus and fetal outcome: protocol for a double-blind randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-055314 ◽

2022 ◽

Vol 12 (1) ◽

pp. e055314

Author(s):

Ibrahim Ibrahim ◽

Hala Abdullahi ◽

Yassin Fagier ◽

Osman Ortashi ◽

Annalisa Terrangera ◽

...

Keyword(s):

Diabetes Mellitus ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Controlled Trial ◽

Tolerance Test ◽

Dietary Advice ◽

Controlled Clinical Trial ◽

Oral Glucose ◽

Double Blind ◽

Registration Number

IntroductionGestational diabetes mellitus (GDM) affects 23.6% of Qatari women and is associated with maternal and perinatal morbidity and long-term risk of developing type 2 diabetes. A number of challenges exist with current interventions, including non-compliance with dietary advice, the reluctance of mothers to ingest metformin tablets or use insulin injections. These challenges highlight the importance of pursuing evidence-based prevention strategies. Myo-inositol is readily available as an US Food and Drug Administration-approved food supplement with emerging but limited evidence suggesting it may be beneficial in reducing the incidence of GDM. Further studies, such as this one, from different ethnic contexts and with differing risk factors, are urgently needed to assess myo-inositol effects on maternal and neonatal outcomes.Methods and analysisThis study is a prospective, randomised, double-blinded, placebo controlled clinical trial to either myo-inositol supplementation or placebo.We plan to enrol 640 pregnant women attending antenatal care at Sidra Medicine, Doha, Qatar, 320 in each arm. All participants will complete at least 12 weeks of supplementation prior to undertaking the Oral Glucose Tolerance Test at 24–28 weeks. The daily use of the trial supplementation will continue until the end of pregnancy. All outcome measures will be collected from the electronic medical records.Ethics and disseminationEthical approval for the study was obtained on 12 April 2021 from Sidra Medicine (IRB number 1538656). Results of the primary trial outcome and secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberProspectively registered on 26 May 2021. Registration number ISRCTN16448440 (ISRCTN registry).

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Effects of 16-Week Consumption of Caffeinated and Decaffeinated Instant Coffee on Glucose Metabolism in a Randomized Controlled Trial

Journal of Nutrition and Metabolism ◽

10.1155/2012/207426 ◽

2012 ◽

Vol 2012 ◽

pp. 1-9 ◽

Cited By ~ 37

Author(s):

Keizo Ohnaka ◽

Mizuko Ikeda ◽

Takako Maki ◽

Tomoko Okada ◽

Takao Shimazoe ◽

...

Keyword(s):

Glucose Tolerance ◽

Controlled Trial ◽

Area Under The Curve ◽

Coffee Consumption ◽

Tolerance Test ◽

Oral Glucose ◽

Instant Coffee ◽

Glucose Levels ◽

Decaffeinated Coffee ◽

Caffeinated Coffee

Objective. Observational studies have shown a protective association between coffee consumption and type 2 diabetes mellitus whereas caffeine or caffeinated coffee acutely deteriorates glucose tolerance. We investigated the effects of chronic drinking of instant coffee on glucose and insulin concentrations during a 75 g oral glucose tolerance test.Methods. Overweight men with a mild-to-moderate elevation of fasting plasma glucose were randomly allocated to a 16-week intervention of consuming 5 cups of caffeinated (n=17) or decaffeinated (n=15) instant coffee per day or no coffee (n=13).Results. The caffeinated coffee group showed statistically significant decreases in the 2-hour concentrations and the area under the curve of glucose while neither decaffeinated coffee nor coffee group showed such a change. Waist circumstance decreased in the caffeinated coffee group, increased in the decaffeinated coffee group, and did not change in the noncoffee group (P=0.002). With adjustment for the change in waist circumference, caffeinated and decaffeinated coffee consumption were associated with a modest decrease in the postload glucose levels.Conclusion. Both caffeinated and decaffeinated coffee may be protective against deterioration of glucose tolerance.

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A RANDOMIZED CONTROLLED TRIAL OF METFORMIN FOR FRAILTY PREVENTION: STUDY DESIGN AND BASELINE CHARACTERISTICS

Innovation in Aging ◽

10.1093/geroni/igz038.2517 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

pp. S682-S682

Author(s):

Sara E Espinoza ◽

Nicolas Musi ◽

Chen-pin Wang ◽

Joel Michalek

Keyword(s):

Randomized Controlled Trial ◽

Glucose Tolerance ◽

Physical Performance ◽

Study Design ◽

Controlled Trial ◽

Tolerance Test ◽

Oral Glucose ◽

Double Blind ◽

Randomized Controlled ◽

Insulin Clamp

Abstract Inflammation and insulin resistance are major predictors of frailty. Here we describe the study design of an ongoing double-blind, randomized controlled trial of metformin for frailty prevention. Subjects are adults aged 65+ years with pre-diabetes assessed by 2-hour oral glucose tolerance test (OGTT). Those who are frail (Fried criteria) are excluded. Participants are randomized to metformin (maximum dose of 2,000 mg/day) vs. placebo and followed for 2 years. The primary outcome is frailty (category and score); secondary outcomes are physical performance and function (short physical performance battery, 6-minute walk, lower extremity strength), systemic and skeletal muscle tissue inflammation, muscle insulin signaling, insulin sensitivity (insulin clamp), glucose tolerance (OGTT), and body composition (dual-energy x-ray absorptiometry). Safety assessments occur every 3 months; frailty, systemic inflammation, and OGTT are assessed at baseline and every 6 months, and insulin clamp with muscle biopsies are assessed at baseline and every 12 months. To date, 51 subjects have been randomized; 120 completers are planned. Mean age is 73.4 ±5.7 years, 43% are female, and 39% Hispanic. Mean BMI is 30.5 ±5.5 kg/m2, waist circumference is 105 ±13.1 cm, fasting glucose is 102.3 ±8.8 mg/dL, Hemoglobin A1c is 5.8 ±0.3, and glucose at 2 hours during OGTT is 168.5 ±20.4 mg/dL. Metformin is being examined in this study as a potential therapeutic agent to prevent frailty in older adults with pre-diabetes. Findings from this trial may have future implications for the screening and potential treatment of pre-diabetes in older patients with metformin for the prevention of frailty.

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Use of carnosine in the prevention of cardiometabolic risk factors in overweight and obese individuals: study protocol for a randomised, double-blind placebo-controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-043680 ◽

2021 ◽

Vol 11 (5) ◽

pp. e043680

Author(s):

Kirthi Menon ◽

James D Cameron ◽

Maximilian de Courten ◽

Barbora de Courten

Keyword(s):

Risk Factors ◽

Cardiovascular Risk ◽

Glucose Metabolism ◽

Glucose Tolerance ◽

Glucose Tolerance Test ◽

Controlled Trial ◽

Tolerance Test ◽

Oral Glucose ◽

Oral Glucose Tolerance ◽

Double Blind

IntroductionCarnosine, an over the counter food supplement, has been shown to improve glucose metabolism as well as cardiovascular risk factors in animal and human studies through its anti-inflammatory, antioxidative, antiglycating and chelating properties. The aim of this study is to establish if carnosine supplementation improves obesity, insulin sensitivity, insulin secretion, cardiovascular risk factors including arterial stiffness and endothelial function, and other risk factors related to diabetes and cardiovascular disease in the overweight and obese population.Methods and analysisFifty participants will be recruited to be enrolled in a double-blind randomised controlled trial. Eligible participants with a body mass index (BMI) between 25 and 40 kg/m2 will be randomly assigned to the intervention or placebo group. Following a medical review and oral glucose tolerance test to check eligibility, participants will then undergo testing. At baseline, participants will have anthropometric measurements (BMI, dual X-ray absorptiometry and peripheral quantitative CT scan), measurements of glucose metabolism (oral glucose tolerance test, intravenous glucose tolerance test and euglycaemic hyperinsulinaemic clamp), cardiovascular measurements (central blood pressure, endothelial function and arterial stiffness), a muscle and fat biopsy, physical activity measurement, liver fibroscan, cognitive function and questionnaires to assess dietary habits, sleep quality, depression, and quality of life. Following baseline assessments, participants will be randomised to either 2 g carnosine or placebo for 15 weeks. In the 15th week, all assessments will be repeated. The preplanned outcome metric is the change between baseline and follow-up measures.Ethics and disseminationThis study is approved by the Human Research Ethics Committee of Monash Health and Monash University, Australia.Trial registration numberNCT02686996.

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Glucose area under the curve during oral glucose tolerance test as an index of glucose intolerance

Diabetology International ◽

10.1007/s13340-015-0212-4 ◽

2015 ◽

Vol 7 (1) ◽

pp. 53-58 ◽

Cited By ~ 21

Author(s):

Kazuhiko Sakaguchi ◽

Kazuo Takeda ◽

Mitsuo Maeda ◽

Wataru Ogawa ◽

Toshiyuki Sato ◽

...

Keyword(s):

Glucose Tolerance ◽

Oral Glucose Tolerance Test ◽

Glucose Intolerance ◽

Glucose Tolerance Test ◽

Area Under The Curve ◽

Tolerance Test ◽

Oral Glucose ◽

Oral Glucose Tolerance

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Fructose Consumption Contributes to Hyperinsulinemia in Adolescents With Obesity Through a GLP-1–Mediated Mechanism

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jc.2019-00161 ◽

2019 ◽

Vol 104 (8) ◽

pp. 3481-3490 ◽

Cited By ~ 4

Author(s):

Alfonso Galderisi ◽

Cosimo Giannini ◽

Michelle Van Name ◽

Sonia Caprio

Keyword(s):

Glucose Tolerance ◽

Mixed Model ◽

Linear Mixed Model ◽

Cell Function ◽

Insulin Response ◽

Tolerance Test ◽

Oral Glucose ◽

Double Blind ◽

Obesity And Diabetes ◽

Glucose Ingestion

Abstract Context The consumption of high-fructose beverages is associated with a higher risk for obesity and diabetes. Fructose can stimulate glucagon-like peptide 1 (GLP-1) secretion in lean adults, in the absence of any anorexic effect. Objective We hypothesized that the ingestion of glucose and fructose may differentially stimulate GLP-1 and insulin response in lean adolescents and adolescents with obesity. Design We studied 14 lean adolescents [four females; 15.9 ± 1.6 years of age; body mass index (BMI), 21.8 ± 2.2 kg/m2] and 23 adolescents with obesity (five females; 15.1 ± 1.6 years of age; BMI, 34.5 ± 4.6 kg/m2). Participants underwent a baseline oral glucose tolerance test to determine their glucose tolerance and estimate insulin sensitivity and β-cell function [oral disposition index (oDIcpep)]. Eligible subjects received, in a double-blind, crossover design, 75 g of glucose or fructose. Plasma was obtained every 10 minutes for 60 minutes for the measures of glucose, insulin, and GLP-1 (radioimmunoassay) and glucose-dependent insulinotropic polypeptide (GIP; ELISA). Incremental glucose and hormone levels were compared between lean individuals and those with obesity by a linear mixed model. The relationship between GLP-1 increment and oDIcpep was evaluated by regression analysis. Results Following the fructose challenge, plasma glucose excursions were similar in both groups, yet the adolescents with obesity exhibited a greater insulin (P < 0.001) and GLP-1 (P < 0.001) increase than did their lean peers. Changes in GIP were similar in both groups. After glucose ingestion, the GLP-1 response (P < 0.001) was higher in the lean group. The GLP-1 increment during 60 minutes from fructose drink was correlated with a lower oDIcpep (r2 = 0.22, P = 0.009). Conclusion Fructose, but not glucose, ingestion elicits a higher GLP-1 and insulin response in adolescents with obesity than in lean adolescents. Fructose consumption may contribute to the hyperinsulinemic phenotype of adolescent obesity through a GLP-1–mediated mechanism.

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Plasma Metabolomics to Identify and Stratify Patients With Impaired Glucose Tolerance

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jc.2019-01104 ◽

2019 ◽

Vol 104 (12) ◽

pp. 6357-6370 ◽

Cited By ~ 4

Author(s):

Charlotte Wildberg ◽

Annette Masuch ◽

Kathrin Budde ◽

Gabi Kastenmüller ◽

Anna Artati ◽

...

Keyword(s):

Glucose Tolerance ◽

Impaired Glucose Tolerance ◽

Area Under The Curve ◽

Tolerance Test ◽

Proton Nuclear Magnetic Resonance ◽

Oral Glucose ◽

Resonance Spectroscopy ◽

Insulin Levels ◽

Model Combining ◽

Branched Chain

Abstract Objective Impaired glucose tolerance (IGT) is one of the presymptomatic states of type 2 diabetes mellitus and requires an oral glucose tolerance test (OGTT) for diagnosis. Our aims were twofold: (i) characterize signatures of small molecules predicting the OGTT response and (ii) identify metabolic subgroups of participants with IGT. Methods Plasma samples from 827 participants of the Study of Health in Pomerania free of diabetes were measured using mass spectrometry and proton-nuclear magnetic resonance spectroscopy. Linear regression analyses were used to screen for metabolites significantly associated with the OGTT response after 2 hours, adjusting for baseline glucose and insulin levels as well as important confounders. A signature predictive for IGT was established using regularized logistic regression. All cases with IGT (N = 159) were selected and subjected to unsupervised clustering using a k-means approach. Results and Conclusion In total, 99 metabolites and 22 lipoprotein measures were significantly associated with either 2-hour glucose or 2-hour insulin levels. Those comprised variations in baseline concentrations of branched-chain amino ketoacids, acylcarnitines, lysophospholipids, or phosphatidylcholines, largely confirming previous studies. By the use of these metabolites, subjects with IGT segregated into two distinct groups. Our IGT prediction model combining both clinical and metabolomics traits achieved an area under the curve of 0.84, slightly improving the prediction based on established clinical measures. The present metabolomics approach revealed molecular signatures associated directly to the response of the OGTT and to IGT in line with previous studies. However, clustering of subjects with IGT revealed distinct metabolic signatures of otherwise similar individuals, pointing toward the possibility of metabolomics for patient stratification.

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Serum angiopoietin-like 3 levels are elevated in obese non diabetic men but are unaffected during an oral glucose tolerance test

Scientific Reports ◽

10.1038/s41598-020-77961-8 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Maria Fernanda Garcés ◽

Julieth Daniela Buell-Acosta ◽

Haiver Antonio Rodríguez-Navarro ◽

Estefania Pulido-Sánchez ◽

Juan José Rincon-Ramírez ◽

...

Keyword(s):

Glucose Tolerance ◽

Oral Glucose Tolerance Test ◽

Glucose Tolerance Test ◽

Area Under The Curve ◽

Serum Levels ◽

Tolerance Test ◽

Oral Glucose ◽

Oral Glucose Tolerance ◽

Matsuda Index ◽

Obese Subjects

AbstractThis study aimed to determine ANGPTL3 serum levels in healthy young lean and obese non-diabetic men during an oral glucose tolerance test (OGTT) and correlate them with anthropometric, biochemical and hormonal parameters. A case–control study was carried out and 30 young obese non-diabetic (23.90 ± 3.84 years and BMI 37.92 ± 4.85 kg/m2) and 28 age-matched healthy lean (24.56 ± 3.50 years and BMI of 22.10 ± 1.72 kg/m2) men were included in this study. The primary outcome measures were serum basal ANGPTL3 and ANGPTL3–area under the curve (AUC) levels. The percentage of body fat was measured by dual-energy X-ray absorptiometry and biochemical, hormonal and insulin resistance indices were determined. Basal ANGPTL3 and ANGPTL3–AUC levels were significantly elevated (p < 0.05) in young obese subjects compared with lean subjects and were positively and significantly associated with different anthropometric measurements. Fasting ANGPTL3 serum levels were positively correlated with fasting insulin, leptin, Leptin/Adiponectin index and triglyceride—glucose index. Moreover, ANGPTL3–AUC was negatively correlated with Matsuda index. In this regard, chronically high ANGPTL3 levels in young obese subjects might favor triglyceride-rich lipoprotein clearance to replenish triglyceride stores by white adipose tissue rather than oxidative tissues.

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Efficacy of individualized homeopathic medicines in primary dysmenorrhea: a double-blind, randomized, placebo-controlled, clinical trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0512 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Shubhamoy Ghosh ◽

Rai Khushboo Ravindra ◽

Amila Modak ◽

Shukdeb Maiti ◽

Arunava Nath ◽

...

Keyword(s):

Repeated Measures ◽

Rating Scales ◽

Controlled Trial ◽

Attrition Rate ◽

Effect Sizes ◽

Secondary Outcome ◽

Systematic Research ◽

Controlled Clinical Trial ◽

Serious Adverse Events ◽

Double Blind

Abstract Objectives Homeopathic treatment is claimed to be beneficial for primary dysmenorrhoea (PD); still, systematic research evidences remain compromised. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IH) against placebo in the treatment of PD. Methods A double-blind, randomized, placebo-controlled trial was conducted at the gynecology outpatient department of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IH (n=64) or identical-looking placebo (n=64). Primary and secondary outcome measures were 0–10 numeric rating scales (NRS) measuring intensity of pain of dysmenorrhea and verbal multidimensional scoring system (VMSS) respectively; all measured at baseline, and every month, up to 3 months. Group differences and effect sizes (Cohen’s d) were calculated on intention-to-treat (ITT) sample. Results Groups were comparable at baseline (all p>0.05). Attrition rate was 10.9% (IH: 7, placebo: 7). Differences between groups in both pain NRS and VMSS favoured IH over placebo at all time points (all p<0.001, unpaired t-tests and two-ways repeated measures analysis of variance) with medium to large effect sizes. Natrum muriaticum and Pulsatilla nigricans (n=20 each; 15.6%) were the most frequently prescribed medicines. No harms, serious adverse events and intercurrent illnesses were recorded in either of the groups. Conclusions Homeopathic medicines acted significantly better than placebo in the treatment of PD. Independent replication is warranted. Trial registration: CTRI/2018/10/016013.

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