Browsing by Subject "HbA1c"
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Item Almond Consumption Decreases Android Fat Mass Percentage in Adults With High Android Subcutaneous Adiposity but Does Not Change HbA1c(Elsevier, 2021) Hunter, Stephanie; Considine, Robert; Mattes, Richard; Medicine, School of MedicineObjectives: The purpose of this study was to determine if the mixed evidence of almond consumption on HbA1c stems from testing people with different body fat distributions (BFD) associated with different risks of glucose intolerance. Methods: A 6-month RCT in 134 adults was conducted. Participants were randomly assigned to the almond or control treatment based on their BFD. Those in the almond group consumed 0.75 oz of almonds with their breakfast and as their afternoon snack (1.5 oz almonds/day) every day, and were instructed not to consume any other nuts. Those in the control treatment continued their habitual breakfast and afternoon snack routines, but were instructed not to consume any nuts. At 0 and 6 months, body composition was measured and blood samples were collected for analyses of HbA1c, glycemia and lipemia. Appetite and dietary intake data were recorded at 0, 2, 4, and 6 months and a blood sample was obtained for compliance testing. Body weight was measured every two weeks. An intention-to-treat linear mixed model analysis was performed with Bonferroni pairwise comparisons on diet quality, energy intake, HbA1c, and body composition change values. Results: Incorporating almonds into the diet increased total diet quality by 8.3 ± 2.1% over the intervention (P = 0.001). Participants consuming almonds ingested 195 ± 87 kcals/day more than participants in the control group (P = 0.027), but this did not result in differences in body weight (P > 0.3). The almond, high android subcutaneous adiposity (SAT) group had a greater reduction in android fat mass % (P = 0.038), preserved android lean mass % (P = 0.042), and tended to decrease android VAT mass (P = 0.079) compared to those in the control, high SAT group. There were no differences of HbA1c between groups (P > 0.05). Conclusions: Incorporating 1.5-oz of almonds into the diet improves diet quality without promoting positive energy balance and weight gain. Long-term consumption of almonds may also improve android composition in those with high android SAT. However, testing people with different BFD does not account for the mixed evidence on almond consumption and HbA1c.Item Almond consumption decreases android fat mass percentage in adults with high android subcutaneous adiposity but does not change HbA1c in a randomised controlled trial(Cambridge University Press, 2022) Hunter, Stephanie R.; Considine, Robert V.; Mattes, Richard D.; Medicine, School of MedicineThe purpose of this study was to determine if the mixed evidence of almond consumption on HbA1c stems from testing people with different body fat distributions (BFD) associated with different risks of glucose intolerance. A 6-month randomised controlled trial in 134 adults was conducted. Participants were randomly assigned to the almond (A) or control (C) group based on their BFD. Those in the almond group consumed 1·5 oz of almonds with their breakfast and as their afternoon snack daily. Those in the control group continued their habitual breakfast and afternoon snack routines. Body weight and composition were measured and blood samples were collected for determination of HbA1c, glycaemia and lipaemia at 0 and 6 months. Appetite ratings, energy intake and diet quality were collected at 0, 2, 4 and 6 months. Participants consuming almonds ingested 816 (sem 364) kJ/d more than participants in the control group (P = 0·03), but this did not result in any differences in body weight (A: –0·3 (sem 0·4), C: –0·4 (sem 0·4); P > 0·3). Participants in the almond, high android subcutaneous adipose tissue (SAT) group had a greater reduction in android fat mass percentage (A: –1·0 (sem 0·6), C: 1·1 (sem 0·6); P = 0·04), preserved android lean mass percentage (A: 0·9 (sem 0·6), C: –1 (sem 0·6); P = 0·04) and tended to decrease android visceral adipose tissue mass (A: –13 (sem 53) g, C: 127 (sem 53) g; P = 0·08) compared with those in the control, high SAT group. There were no differences in HbA1c between groups (A: 5·4 (sem 0·04), C: 5·5 (sem 0·04); P > 0·05). Thus, BFD may not explain the mixed evidence on almond consumption and HbA1c. Long-term almond consumption has limited ability to improve cardiometabolic health in those who are overweight and obese but otherwise healthy.Item Changes in Basal and Bolus Insulin Requirements with Tirzepatide as an Adjunctive Therapy in Adults with Type 1 Diabetes Using Tandem Control-IQ(Springer, 2024) Karakus, Kagan E.; Klein, Matthew P.; Akturk, Halis K.; Shah, Viral N.; Medicine, School of MedicineIntroduction: This study was aimed at investigating changes in insulin requirements and glycemic outcomes in adults with type 1 diabetes (T1D) using Control IQ (Tandem Diabetes) automated insulin delivery system (AID) over 8 months of tirzepatide treatment. Methods: In this single-center, observational study, we collected demographic, A1c, weight, sensor glucose, and insulin dose data for adults with T1D who were using AID and initiated tirzepatide adjunct therapy for clinical indications (n = 11, median age 37, 64% female and mean body mass index of 39.6 kg/m2). Data were compared from baseline and over 8 months. Results: Within 2 months of tirzepatide treatment, there were significant reductions in total daily insulin [median (IQR) 73.9 (47.6-95.8) to 51.7 (46.7-66.8) units/day, p < 0.001], basal insulin [47 (28.2-51.8) to 32.4 (25.5-46.3) units/day, p < 0.001], and bolus insulin [31.4 (19.9-38.3) to 17.9 (14.9-22.2) units/day, p < 0.001] requirements. Insulin dose reduction from 2 to 8 months was modest. The frequency of user-initiated boluses did not differ throughout the study. Despite reductions in total insulin requirement, time in range (70-180 mg/dl) increased by 7%, A1c reduced by 0.5%, weight reduced by 9%, without increase in time below 70 mg/dl. Conclusions: This pilot study provides clinical guidance on insulin titration for adults with T1D who may initiate tirzepatide therapy. Based on the findings of this study, we recommend reducing 25% of total daily insulin dose at tirzepatide initiation in adults with T1D using AID with baseline A1c of less than 7.5%. Higher doses of tirzepatide were associated with greater weight loss, however, the reduction in insulin requirement was minimal.Item Consensus Report on Glucagon-Like Peptide-1 Receptor Agonists as Adjunctive Treatment for Individuals With Type 1 Diabetes Using an Automated Insulin Delivery System(Sage, 2024-11-08) Shah, Viral N.; Peters, Anne L.; Umpierrez, Guillermo E.; Sherr, Jennifer L.; Akturk, Halis Kaan; Aleppo, Grazia; Bally, Lia; Cengiz, Eda; Cinar, Ali; Dungan, Kathleen; Fabris, Chiara; Jacobs, Peter G.; Lal, Rayhan A.; Mader, Julia K.; Masharani, Umesh; Prahalad, Priya; Schmidt, Signe; Zijlstra, Eric; Ho, Cindy N.; Ayers, Alessandra T.; Tian, Tiffany; Aaron, Rachel E.; Klonoff, David C.; Medicine, School of MedicineWith increasing prevalence of obesity and cardiovascular diseases, there is a growing interest in the use of glucagon-like peptide-1 receptor agonists (GLP-1RAs) as an adjunct therapy in type 1 diabetes (T1D). The GLP-1RAs are currently not approved by the US Food and Drug Administration for the treatment of T1D in the absence of randomized controlled trials documenting efficacy and safety of these agents in this population. The Diabetes Technology Society convened a series of three consensus meetings of clinicians and researchers with expertise in diabetes technology, GLP-1RA therapy, and T1D management. The project was aimed at synthesizing current literature and providing conclusions on the use of GLP-1RA therapy as an adjunct to automated insulin delivery (AID) systems in adults with T1D. The expert panel members met virtually three times on January 17, 2024, and April 24, 2024, and August 14, 2024, to discuss topics ranging from physiology and outcomes of GLP-1RAs in T1D to limitations of current sensors, algorithms, and insulin for AID systems. The panelists also identified research gaps and future directions for research. The panelists voted to in favor of 31 recommendations. This report presents the consensus opinions of the participants that, in adults with T1D using AID systems, GLP-1RAs have the potential to (1) provide effective adjunct therapy and (2) improve glycemic and metabolic outcomes without increasing the risk of severe hypoglycemia or diabetic ketoacidosis.Item Efficacy and Safety of Tirzepatide in Adults With Type 1 Diabetes: A Proof of Concept Observational Study(Sage, 2024-02-05) Akturk, Halis Kaan; Dong, Fran; Snell-Bergeon, Janet K.; Karakus, Kagan Ege; Shah, Viral N.; Medicine, School of MedicineBackground: Tirzepatide is approved by the United States Food and Drug Administration (FDA) for the management of type 2 diabetes. The efficacy and safety of this drug have not been studied in people with type 1 diabetes (T1D). Methods: In this single-center, retrospective, observational study, hemoglobin A1C (HbA1c), weight, body mass index (BMI), and continuous glucose monitoring (CGM) data were collected from electronic health records of adults with T1D at initiation of tirzepatide and at subsequent clinic visits over 8 months. Primary outcomes were reduction in HbA1c and percent change in body weight and secondary outcomes were change in CGM metrics and BMI over 8 months from baseline. Results: The mean (±SD) age of the 26 adults (54% female) with T1D was 42 ± 8 years with a mean BMI of 36.7 ± 5.3 kg/m2. There was significant reduction in HbA1c by 0.45% at 3 months and 0.59% at 8 months, and a significant reduction in body weight by 3.4%, 10.5%, and 10.1% at 3, 6, and 8 months after starting tirzepatide. Time in target range (TIR = 70-180 mg/dL) and time in tight target range (TITR = 70-140 mg/dL) increased (+12.6%, P = .002; +10.7%, P = .0016, respectively) and time above range (TAR >180 mg/dL) decreased (-12.6%, P = .002) at 3 months, and these changes were sustained over 8 months. The drug was relatively safe and well tolerated with only 2 patients discontinuing the medication. Conclusions: Tirzepatide significantly reduced HbA1c and body weight in adults with T1D. A randomized controlled trial is needed to establish efficacy and safety of this drug in T1D.Item Evaluation of a Participant Co-designed Lifestyle Change Program for Youth(2022-05) Alharbi, Basmah Saleh; Perkins, Susan M.; Hannon, Tamara S.; Daggy, Joanne K.Introduction: Increasing obesity in children leads to an increase in the risk of Type 2 diabetes (T2D). Therefore, it is important to promote healthier lifestyles in youths and encourage their caregivers(s) to provide a healthy lifestyle environment. The PowerHouse program focuses on improving food choices, increasing physical activity, and adopting behavior changes for the reduction of obesity and the prevention of T2D. Method: The aim of this study was to assess the effects of implementing the PowerHouse program on both clinical and quality of life outcomes in high-risk, low-income youth and their caregivers. Primary outcomes were BMI standard deviation and BMI percentile in youths. Secondary outcomes included physical activity of youths and quality of life for both youths and their caregivers. Attendance rates were also calculated. Linear effect mixed models were used to test for time effects for all outcomes. Results: Clinical outcomes did not improve over time, except for youth HbA1c (p-value = 0.0447). Some improvements in youth quality-of-life outcomes were noted: specifically, the Sports Index score of the Fels Physical Activity Questionnaire for Children (adjusted p-value = 0.0213) and the Physical Summary (p-value = 0.0407), Psychosocial Summary (p-value = 0.0167), and Total score (p-value = 0.0094) for the youth-reported Pediatric Quality of Life Inventory. Quality of life did not change over time for caregivers. For attendance, there was an improvement after the intervention was modified to improve access to fresh produce (p-value = 0.0002). Conclusion: HbA1c and quality of life improved over time for youth; however, there was not an improvement in caregiver outcomes over time. The data suggest that more time may be needed to see the full effects of the intervention, and/or that a booster intervention may be needed.Item Hyperglycemia, symptoms, and symptom clusters in colorectal cancer survivors with type 2 diabetes(Springer, 2022-12) Storey, Susan; Luo, Xiao; Ofner, Susan; Perkins, Susan M.; Von Ah, Diane; School of NursingPurpose The purpose of the study was to compare the individual and total number of symptoms and explore symptom clusters by hyperglycemia status in colorectal cancer survivors (CRCS) with diabetes (type 2). Methods A retrospective cohort study was conducted, whereby symptom data were extracted from clinical notes in electronic health records. CRCS (stage II or III) diagnosed between 2007 and 2017 who had diabetes and at least one HbA1c within 8 months of initial chemotherapy were included. Zero-inflated negative binomial regression analysis was used to examine total symptoms by hyperglycemia status (hyperglycemia versus no hyperglycemia). Exploratory factor analysis was conducted to identify symptom clusters. Results Two hundred forty-three CRCS met inclusion criteria. CRCS with hyperglycemia (HbA1c ≥ 6.5%) had greater individual symptoms (fatigue and depression) and total number of symptoms than those with no hyperglycemia. Two distinct symptom clusters, with five (nausea, vomiting, constipation, fatigue, and peripheral neuropathy) and two symptoms (anxiety and depression), were identified among CRCS with hyperglycemia. Conclusion These findings indicate that CRCS with diabetes and hyperglycemia had more symptoms and two distinct symptom clusters compared to those with no hyperglycemia. Prospective research studies are needed to examine the role of hyperglycemia in symptoms among CRCS with diabetes. Understanding hyperglycemia’s influence is important as it is a modifiable risk factor towards which prevention and intervention can be directed, potentially mitigating symptoms and symptom clusters and improving outcomes for CRCS with diabetes.Item Index60 Is Superior to HbA1c for Identifying Individuals at High Risk for Type 1 Diabetes(Oxford University Press, 2022) Jacobsen, Laura M.; Bundy, Brian N.; Ismail, Heba M.; Clements, Mark; Warnock, Megan; Geyer, Susan; Schatz, Desmond A.; Sosenko, Jay M.; Pediatrics, School of MedicineContext: HbA1c from ≥ 5.7% to < 6.5% (39-46 mmol/mol) indicates prediabetes according to American Diabetes Association guidelines, yet its identification of prediabetes specific for type 1 diabetes has not been assessed. A composite glucose and C-peptide measure, Index60, identifies individuals at high risk for type 1 diabetes. Objective: We compared Index60 and HbA1c thresholds as markers for type 1 diabetes risk. Methods: TrialNet Pathway to Prevention study participants with ≥ 2 autoantibodies (GADA, IAA, IA-2A, or ZnT8A) who had oral glucose tolerance tests and HbA1c measurements underwent 1) predictive time-dependent modeling of type 1 diabetes risk (n = 2776); and 2) baseline comparisons between high-risk mutually exclusive groups: Index60 ≥ 2.04 (n = 268) vs HbA1c ≥ 5.7% (n = 268). The Index60 ≥ 2.04 threshold was commensurate in ordinal ranking with the standard prediabetes threshold of HbA1c ≥ 5.7%. Results: In mutually exclusive groups, individuals exceeding Index60 ≥ 2.04 had a higher cumulative incidence of type 1 diabetes than those exceeding HbA1c ≥ 5.7% (P < 0.0001). Appreciably more individuals with Index60 ≥ 2.04 were at stage 2, and among those at stage 2, the cumulative incidence was higher for those with Index60 ≥ 2.04 (P = 0.02). Those with Index60 ≥ 2.04 were younger, with lower BMI, greater autoantibody number, and lower C-peptide than those with HbA1c ≥ 5.7% (P < 0.0001 for all comparisons). Conclusion: Individuals with Index60 ≥ 2.04 are at greater risk for type 1 diabetes with features more characteristic of the disorder than those with HbA1c ≥ 5.7%. Index60 ≥ 2.04 is superior to the standard HbA1c ≥ 5.7% threshold for identifying prediabetes in autoantibody-positive individuals. These findings appear to justify using Index60 ≥ 2.04 as a prediabetes criterion in this population.Item Metabolic and Skeletal Characterization of the KK/Ay Mouse Model – a Polygenic Mutation Model of Obese Type 2 Diabetes(Springer, 2024) Chowdhury, Nusaiba N.; Surowiec, Rachel K.; Kohler, Rachel K.; Reul, Olivia N.; Segvich, Dyann M.; Wallace, Joseph M.; Radiology and Imaging Sciences, School of MedicineType 2 diabetes (T2D) increases fracture incidence and fracture-related mortality rates (KK.Cg-Ay/J. The Jackson Laboratory; Available from: https://www.jax.org/strain/002468 ). While numerous mouse models for T2D exist, few effectively stimulate persistent hyperglycemia in both sexes, and even fewer are suitable for bone studies. Commonly used models like db/db and ob/ob have altered leptin pathways, confounding bone-related findings since leptin regulates bone properties (Fajardo et al. in Journal of Bone and Mineral Research 29(5): 1025-1040, 2014). The Yellow Kuo Kondo (KK/Ay) mouse, a polygenic mutation model of T2D, is able to produce a consistent diabetic state in both sexes and addresses the lack of a suitable model of T2D for bone studies. The diabetic state of KK/Ay stems from a mutation in the agouti gene, responsible for coat color in mice. This mutation induces ectopic gene expression across various tissue types, resulting in diabetic mice with yellow fur coats (Moussa and Claycombe in Obesity Research 7(5): 506-514, 1999). Male and female KK/Ay mice exhibited persistent hyperglycemia, defining them as diabetic with blood glucose (BG) levels consistently exceeding 300 mg/dL. Notably, male control mice in this study were also diabetic, presenting a significant limitation. Nevertheless, male and female KK/Ay mice showed significantly elevated BG levels, HbA1c, and serum insulin concentration when compared to the non-diabetic female control mice. Early stages of T2D are characterized by hyperglycemia and hyperinsulinemia resulting from cellular insulin resistance, whereas later stages may feature hypoinsulinemia due to β-cell apoptosis (Banday et al. Avicenna Journal of Medicine 10(04): 174-188, 2020 and Klein et al. Cell Metabolism 34(1): 11-20, 2022). The observed hyperglycemia, hyperinsulinemia, and the absence of differences in β-cell mass suggest that KK/Ay mice in this study are modeling the earlier stages of T2D. While compromised bone microarchitecture was observed in this study, older KK/Ay mice, representing more advanced stages of T2D, might exhibit more pronounced skeletal manifestations. Compared to the control group, the femora of KK/Ay mice had higher cortical area and cortical thickness, and improved trabecular properties which would typically be indicative of greater bone strength. However, KK/Ay mice displayed lower cortical tissue mineral density in both sexes and increased cortical porosity in females. Fracture instability toughness of the femora was lower in KK/Ay mice overall compared to controls. These findings indicate that decreased mechanical integrity noted in the femora of KK/Ay mice was likely due to overall bone quality being compromised.Item Reproducibility of Glycemic Measures Among Dysglycemic Youth and Adults in the RISE Study(The Endocrine Society, 2023) Tjaden, Ashley H.; Edelstein, Sharon L.; Arslanian, Silva; Barengolts, Elena; Caprio, Sonia; Cree-Green, Melanie; Lteif, Amale; Mather, Kieren J.; Savoye, Mary; Xiang, Anny H.; Kahn, Steven E.; Medicine, School of MedicineAims: Previous work found poor reproducibility for measures of glycemia in individuals at risk for dysglycemia. Differences between youth and adults have not been assessed. Using youth and adults in the Restoring Insulin Secretion Study, we tested variability and classification concordance for hemoglobin A1C (HbA1c), fasting and 2-hour glucose from oral glucose tolerance tests (OGTTs). Methods: HbA1c and glucose on repeated samples obtained ∼6 weeks apart were compared in 66 youth (mean age 14.2 years) and 354 adults (52.7 years). Changes, coefficient of variation (CV), and concordance of diagnostic categories between the 2 visits were compared. Results: Mean difference between the 2 visits in HbA1c was higher in youth than adults (P < .001), while fasting glucose was similar and 2-hour glucose was lower in youth (P = .051). CV was smallest for HbA1c compared to fasting and 2-hour glucose. For HbA1c, youth had higher CV (P < .001); whereas CV for 2-hour glucose was lower for youth (P = .041). Classification concordance by HbA1c was lower in youth (P = .004). Using OGTT or HbA1c for classification, intervisit variability produced discordant classification in 20% of youth and 28% of adults. Using both fasting glucose and HbA1c, intervisit variability reduced discordant classification to 16% of adults while not improving classification in youth. Conclusions: Poor reproducibility and lack of classification concordance highlight the limitations of one-time testing, with important implications for assessing eligibility in clinical trials. Consideration should be given to using more than a single parameter for screening and diagnosis, especially when classification category is important.