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Abstracts / Can J Diabetes 41 (2017) S2?S16
37
Body Weight and Energy Intake Changes in Overweight
Individuals Treated with Canagli?ozin, Phentermine, or
Canagli?ozin+Phentermine
DAVID POLIDOR, NATHAN GILL, FRANK VERCRUYSSE,
NGOZI ERONDU, KEVIN D. HALL
San Diego, CA
SGLT2 inhibitors (SGLT2i) induce a caloric loss by increasing urinary
glucose excretion (UGE) leading to a modest yet sustained weight
loss (WL) of ~2-4% in patients with type 2 diabetes. This WL is
much less than predicted based on the UGE caloric de?cit alone
due to compensatory increases in energy intake (EI) that occur in
response to WL. A 26-week study in overweight, otherwise healthy
individuals (N=334, 82% female, mean (SD) age=46 (11) y, body
weight (BW)=103 (18) kg, BMI=37 (5) kg/m2) tested the hypothesis that combining the appetite suppressant phentermine (PHEN
15 mg) with the SGLT2i canagli?ozin (CANA 300 mg) results in
greater WL than either monotherapy. Changes in EI were estimated using a previously validated mathematical model of energy
balance using measured BW pro?les and an estimated UGE of
55 g/day with CANA. As expected, WL was greatest with CANA+PHEN,
and estimated EI was increased with CANA and decreased with
PHEN (Figure). Surprisingly, despite the greater WL with
CANA+PHEN, EI with CANA+PHEN was virtually identical to EI
with PHEN alone, suggesting that co-administration of PHEN was
able to fully block the compensatory EI increase that occurs with
CANA alone. This effect led to greater-than-additive WL with
CANA+PHEN, and individuals were still in negative energy balance
and losing weight at Week 26. Longer-term studies with CANA+PHEN
are warranted.
38
Diabetes in Pregnancy Exposure, Mitochondrial Markers, and
Diastolic Function in Adolescents with Type 2 Diabetes
LAETITIA GUILLEMETTE*, ALLISON DART, BRANDY WICKLOW,
VERNON W. DOLINSKY, DAVINDER JASSAL, ELIZABETH SELLERS,
TODD A. DUHAMEL, JONATHAN MCGAVOCK
Winnipeg, MB
Purpose: Mitochondrial dysfunction is intimately linked to type 2
diabetes (T2D) and cardiovascular disease (CVD). We hypothesized that exposure to diabetes in pregnancy (DiP) would adversely
affect mitochondrial function and CVD risk in youth with T2D.
Methods: We analysed serum metabolomic markers of mitochondrial function/oxidative stress (ultra-performance liquid
chromatography-tandem mass spectroscopy) as well as cardiac diastolic function (echocardiography-measured left ventricular earlyto-late [E/A] blood ?ow velocity) in youth with T2D. DiP exposure
was classi?ed as T2D (n=34), gestational diabetes (n=16), and
normoglycemia (NG; n=38). Signi?cance was set at q (p-value
adjusted for false discovery rate)<0.05.
Results: Groups were similar for sex (62 vs 43 vs 71% female), age
(14.8�7 vs 15.4�8 vs 15.4�6 years), duration of diabetes (3.0,
[interquartile range]: [2.0?5.0] vs 2.0 [1.0?3.5] vs 3.0 [2.0?5.0]years),
S13
fat% (30� vs 31� vs 33�%) and systolic blood pressure load
(45 [22?74] vs 42 [24?53] vs 33 [19?61]%). DiP exposure was not
associated with metabolomic markers of mitochondrial function but
worsened oxidative stress (hydroxyoctadecadienoic acids [13-/9HODE]; T2D/NG ratio=2.20, q=0.02; methionine sulfoxide T2D/NG
ratio=2.06, q=0.01). Mitochondrial metabolomic markers were not
associated with diastolic function (leucine: r=?0.23, q=0.08; isoleucine: r=?0.25, q=0.06; valine: r=?0.22, q=0.09; carnitine: r=0.19,
q=0.13). Oxidative stress was inversely associated with diastolic function (13-/9-HODE: r=?0.23, q=0.08; methionine sulfoxide: r=?0.23,
q=0.08).
Conclusion: Oxidative stress, but not mitochondrial dysfunction,
is associated with DiP exposure and impaired diastolic function in
adolescents with T2D.
39
Parental Decision-Making Processes in Pediatric Trial
Enrollment: Recommendations for Informed Consent in
Juvenile Type 1 Diabetes Research
STEPHANIE KOWAL*, TANIA BUBELA
Edmonton, AB
Background: Clinical trials for novel interventions, including cell
therapies and devices, for Type 1 diabetes are beginning to recruit
pediatric participants. It is, therefore timely to consider how to communicate risks and potential bene?ts of trial participation with
parents who make clinical decisions on behalf of their child. Parents
have high expectations for new treatment options, which may
encourage them to pursue clinical trial opportunities or join risky
movements. For example, the Do It Yourself Pancreas System uses
open access coding communities to share unproven automated
insulin delivery via smartphones.
Methods: We conducted 16 qualitative interviews with parents of
children with Type 1 diabetes to explore information gathering,
decision-making processes, and knowledge of clinical trial conduct
by parents. We used the constant comparison method to code interview transcripts for themes, using NVivo qualitative analysis
software.
Results: Parents? decision-making processes followed Protection
Motivation Theory. This theory posits that parents will use available information to balance the risks of trial participation against
the risks of current disease management. This balancing helps them
decide whether trial enrollment may protect the health of their child
better than current management methods. However, the Theory
needs to account for the overly optimistic information about
treatment research accessed by parents on traditional and social
media. In general, parents are risk-adverse and express a preference for complete and accurate information to make fully informed
decisions.
Conclusion: Parents can differentiate between hope and expectation for trial outcomes. However, their preference for accurate information means that clinicians must clearly communicate therapeutic
potential, likelihoods of risks and bene?ts, as well as uncertainty.
Recommendations for clinical investigators to develop communication protocols that ensure parents receive all necessary risk and
bene?t information will ensure that parental consent for pediatric clinical trials is, in fact, informed.
40
Exposure to Adverse Child Experiences Increase the Odds of
Obesity in Early Adolescence: A Population-Based Prospective
Cohort Study
RACHEL GARDNER, ALLISON FEELY, JON MCGAVOCK
Winnipeg, MB
S14
Abstracts / Can J Diabetes 41 (2017) S2?S16
Rationale: The purpose of this study was to test the hypothesis that
obesity-risk in adolescence is elevated in children expose to adverse
events, in a dose-response manner.
Methods: We performed a prospective analysis of 6942 adolescents and their primary care givers in the Growing Up in Ireland
child cohort study with measurements obtained in children at 9 and
13 yrs of age. Main exposures were adverse experiences before 9
yrs including several Adverse Child Experience (ACEs) exposures.
Main outcome was Objectively measured overweight and obesity
at 13 years of age determined using World Health Organization criteria for age and sex. Confounding included objectively measured
parental weight status, self-reported physical activity and diet, household income, gender, and family structure.
Results: More than 75% of the youth experienced an adverse experience and 17% experienced an ACE- experience before 9 yrs of age.
After adjusting for confounding, exposure to any adverse experience was associated with increased odds of overweight/obesity (aOR:
1.15; 95% CI: 1.00?1.32) and obesity (aOR: 1.35; 95% CI: 1.09?
1.69). These associations were stronger among adolescents living
in lower income households and if children were exposed to ACEspeci?c adverse experiences (overweight/obesity- aOR: 1.21; 95%
CI: 1.01?1.46; obesity- aOR: 1.50; 95% CI: 1.13?1.98).
Conclusions: Childhood adverse experiences, particularly severe
adverse experiences, are independently associated with an increased
risk of obesity in early adolescence. Increased efforts to assess and
address these experiences may improve treatment and prevention efforts for adolescent obesity.
41
Lay- or Expert-Led Interventions for Weight Loss in
Overweight Youth, What Works? A Systematic Review and
Network Meta-Analysis
BHUPENDRASINH F. CHAUHAN, RASHEDA RABBANI,
AHMED M. ABOU-SETTA, RYAN ZARYCHANSKI,
JONATHAN MCGAVOCK
Winnipeg, MB
42
Pregnancy Characteristics and Maternal Risk of Type 2
Diabetes Mellitus
CHRISTY WOOLCOTT*, SARAH D. MCDONALD, HUDE QUAN,
MOHAMED ABDOLELL, TREVOR DUMMER, LINDA DODDS
Halifax, NS
Background: Gestational diabetes mellitus (GDM) is known to be
associated with an approximately seven-fold increased risk of developing type 2 diabetes mellitus (T2DM) in women. Our objective was
to examine other pregnancy characteristics in addition to GDM in
relation to T2DM.
Methods: A population-based retrospective cohort study was conducted with information about women?s ?rst and subsequent pregnancies from the Nova Scotia Atlee Perinatal Database (1988?
2009) and later T2DM from physician claims and hospital discharge
databases (1989?2012). Hazard ratios (HR) with 95% con?dence intervals (CI) adjusted for maternal weight, age at ?rst birth, area-level
income, smoking, and other pregnancy characteristics were estimated.
Results: Among 78,977 women without pre-existing diabetes and
complete data, 2969 (3.8%) developed T2DM over a median 14.8
years of follow-up. GDM was associated with the risk of developing T2DM (HR 7.50, CI 6.90?8.15). Among women with a history of
GDM, pregnancy characteristics also associated with the risk of T2DM
included any history of: Caesarean section (HR 1.16, CI 1.01?1.34);
birthweight for gestational age >90th percentile (HR 1.29, CI 1.11?
1.49); neonatal hypoglycemia (HR 1.40, CI 1.16?1.69); and
breastfeeding (HR 0.79, CI 0.69?0.91). These characteristics were
similarly associated with T2DM risk among women without a history
of GDM; additionally, pre-eclampsia (HR 1.54, CI 1.28?1.84) and gestational hypertension (HR 1.69, CI 1.52?1.87) were associated with
T2DM in this group.
Conclusions: Pregnancy characteristics are associated with the risk
of developing T2DM, including hypertensive disorders of pregnancy among women without a history of GDM.
43
Background: Lay or peer-led approaches are an attractive
option for public health interventions however their effectiveness
for weight loss among overweight youth remains unclear. We conducted a systematic review and network meta-analysis to address
this issue.
Methods: We searched MEDLINE, Embase, the Cochrane Library, and
CINAHL from January 1, 1996 to May 20, 2016 for randomized clinical trials (RCTs) of behavioural weight loss interventions lasting 12
weeks in youth <18 years and strati?ed into 3 arms:1) lay-led; 2)
expert-led; and 3) standard of care. The primary outcomes were
change from baseline in weight and body mass index (BMI). Secondary outcomes were BMI-z score, BMI %tile, percent fat, and study
withdrawals.
Findings: Of 25,586 citations retrieved, 64 RCTs representing 5598
overweight or obese children and adolescents were analyzed (mean
age 11.4 years; 40.7% male). Compared to standard weight loss interventions, expert-led interventions yielded signi?cant reductions in
weight [median difference (MD) ?2.45 Kg, 95% credible interval (CrI)
?3.69 to ?1.32; 15 RCTs] and BMI [MD ?0.90 Kg/m2, 95% CrI ?1.60
to ?0.28; 14 RCTs]. The magnitude of weight reduction associated
with expert-led intervention was maintained even after termination of intervention [MD ?2.50, 95% CrI ?4.40, ?0.83, 6 RCTs]. Layled interventions failed to reach a statistically signi?cant reduction
in weight or BMI, compared to control [MD ?0.71 kg, 95% CrI ?3.40,
1.90 and MD ?1.74 kg/m2, 95% CrI ?4.56, 0.96]
Interpretation: Expert-led approaches are the most effective for
weight reduction among overweight youth. Sparse data on layled weight loss intervention warrants further research.
Implementation and Evaluation of the Metformin First
Protocol for Management of Gestational Diabetes Mellitus
REHA KUMAR, JULIA LOWE, FIONA THOMPSON-HUTCHISON,
DAPHNA STEINBERG, ILANA HALPERIN*
Toronto, ON
Background: In light of growing evidence recommending metformin
as ?rst-line drug therapy for gestational diabetes mellitus(GDM),
the Diabetes in Pregnancy Clinic at Sunnybrook Hospital implemented the ?Metformin First? protocol. Metformin is now offered
to all patients requiring medication for management of GDM.
Objectives & Methods: A retrospective chart review was conducted of GDM patients seen at the clinic prior to(Jan-Jul2015) and
following(Jan-Sept2016) implementation of the protocol to compare
pregnancy outcomes. A prospective patient survey was also administered to evaluate impact on patient satisfaction and clinic e?ciency.
Results: 264 patient charts were reviewed: 159 patients (60%) were
treated with lifestyle modi?cations, 46(17%) with metformin, 40(15%)
with insulin and 19(7%) with metformin+insulin. There were no signi?cant differences in rates of pregnancy complications (obstructed
labour, infants born large for gestational age, NICU admissions and
infant hypoglycemia) or gestational weight gain. Blood glucose
control was also comparable and satisfactory across groups.
Of the 65 patients initially started on metformin, 21(32%) were
switched to or provided supplemental insulin therapy. However, the
overall percentage of patients started on insulin?thus requiring individualized patient training?has decreased signi?cantly(33% in 2015
vs 17% in 2016, p=0.003). Following implementation of the protocol,
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