Diving Be hind T ype 2 Dia b e te s Re ve rsa l He a dline s: - - PowerPoint PPT Presentation

Diving Be hind T ype 2 Dia b e te s Re ve rsa l He a dline s:

WHAT DO WE T E L L OUR PAT I E NT S?

• 1) Ide ntify how r

e ve r sal is de fine d and ac hie ve d ac r

• ss multiple studie s, inc luding

gastr ic bypass studie s

• 2) e xplor

e two biologic al r e asons r e ve r sal patte r ns ar e diffic ult to sustain and the soc ial me ssaging be hind ac hie ve me nt and sustainability of those patte r ns

• 3) list at le ast thr

e e ways to navigate patie nt que stions about type 2 diabe te s r e ve r sal or r e mission

• Wr

ite down 2- 3 que stions or c omme nts you he ar fr

• m patie nts about T

2D r e ve r sal

• What ar

e your pe r sonal fe e lings about T 2D r e ve r sal? Is it possible ? How like ly do you think it is? (wr ite down a pe r c e ntage )

• How do you de fine diabe te s r

e ve r sal?

• “With time and de dic atio n, type 2 diabe te s c an be re ve rse d, and the re sults c an be ve ry

re warding, with le ss tire dne ss and be tte r all-ro und he alth.” - Diabe te s.Co .Uk

• “T

his me ans we c an no w se e type 2 diabe te s as a simple c o nditio n whe re the individual has ac c umulate d mo re fat than the y c an c o pe with . . . thro ugh die t and pe rsiste nc e , patie nts are able to lo se the fat and po te ntially re ve rse the ir diabe te s.” - Pro f. Ro y taylo r, c o -le ad o f DI RE CT study

• “Virta c an re ve rse type 2 diabe te s quic kly and sustainably.” - Virta he alth

Ame ric a n Dia b e te s Asso c ia tio n & Wo rld He a lth Org a niza tio n

A Stor y Of “Re mission”

Ove r vie w of Re ve r sal Studie s & SOS Study De fining T 2D Re ve r sal vs Re mission Compar e & Contr ast Re ve r sal Studie s Conside r ations for

• ur

Patie nts and He althc ar e T e am

• Weight Loss > Or = 15

Kg (33 Lbs)

• Remission: Year 1

Defined By < 6.5%, Off Dm Meds X 2 Months; Year 2 <6.5% Off Meds

• CV Events (MI, CVA,

CV Death, Inpt Tx Chest Pain)

• Weight Loss Goal Of

>7% (Individual Goal 10%)

• Remission A1c <6.5%

X 1 Year, No Meds

(Secondary Outcome)

• Time Before T2D Meds

Needed

• Partial Or Complete

Remission Of T2d

• Weight
• Glycemic Control
• Cardiac Risk Factors
• Retention
• A1c
• HOMA‐IR (Insulin Or C‐

peptide)

• Fasting Glucose
• Fasting Insulin
• Fasting C‐peptide
• Weight

• Primary
• Overall Mortality
• Secondary:
• Changes in body weight, risk factors, energy intake, and physical activity
• Difference in the incidence of risk conditions over 2‐ and 10‐year periods
• Difference in the rate of recovery from risk conditions over 2‐ and 10‐year periods

Torgerson JS, Sjöström L. (2001). The Swedish Obese Subjects (SOS) study‐‐ rationale and results. Romeo, et al (2012)

POPULATION:

• Recruited >1500;
• 298 Included
• T2D W/In 6 Years
• Median 3 Year
• A1c 7.6%
• Medication Use
• Diet Alone 24%
• I Drug 48%
• 2+ Drugs 28%

Diabetes Remission Clinical Trial. Published Results. Retrieved from https://www.directclinicaltrial.org.uk/

PHYSICAL INTERVENTION:

• Initial 30 minutes/day
• Recommended an

additional 15,000 steps per day (approx. 1.5‐2 hours) from 6 months on NUTRITION INTERVENTION:

• 800 calories/day in

form of supplement (60% carb) x 6 month

• Food re‐introduction

after 6 months SUPPORT INTERVENTION:

• Year 1: RD or RN visit

every 2 weeks, then every 4 weeks.

• Year 2: average appts

7.7 over year

• Step counters
• “Relapse”—weight gain

>2kg or diabetes returned: Weight loss med (orlistat), Meal replacement, short term use of daily supplement restarted

“T 2DM is a c o mplic a tio n o f we ig ht g a in a nd e xc e ss b o dy fa t, a nd it is no t ne c e ssa rily a pe rma ne nt c o nditio n.”

POPULATION:

• Recruited 15,500
• 5,145 Included
• T2D W/in 6 Years
• A1c 7.3%
• Medication Use
• Diet Alone 13%
• Non‐Insulin Use

72%

• Insulin 15%
• Higher Education/

Higher Incomes

Wadden, et. al. 2006

PHYSICAL INTERVENTION:

• Initial 30

minutes/day, 6 days a week

• Recommended an

increase to an additional 10,000 steps per day (approx. 1‐1.5 hours) NUTRITION INTERVENTION:

• 1200‐1500 if less than

250 lb; 1500‐1800 > 250 lb

• Encouraged to do 2

meals w/shake or snack bar replacement

• Goal to just eat

restricted intake (wean off supplements)

SUPPORT INTERVENTION:

• RD, psychologists,

exercise physiologists, Weekly x 6 months; 3x/mon next 6 months; (intervention group > 90 )

• Campaigns to continue

motivation & engagement

• Did not meet >5% weight

loss at 6 months or more than 2% weight regain = meal replacement, classes/equipment for cooking/exercise, orlistat

Study wa s sto ppe d e a rly due to la c k o f b e ne fit (no diffe re nc e wa s se e n in CV e ve nts).

MINNE SOT A ST ARVAT ION E XPE RIME NT

• DIRE

CT ST UDY

• 800 Calor

ie s/ Day

• 30 Min + 15,000 + Ste ps/ Day (= 8

Mile s/ Day; 56 Mile s/ We e k)

• L

OOK AHE AD ST UDY

• 1200- 1800 Calor

ie s/ Day

• 30 Min + 10,000 + Ste ps/ Day (= 5

Mile s/ Day; 35 Mile s/ We e k

• MINNE

SOT A ST ARVAT ION E XPE RIME NT

• Calor

ie s 1600— r atione d fur the r if not me e ting we ight loss goals---adjuste d we e kly

• E

xe r c ise –Walk 22 Mile s / We e k (3 Mile s/ Day)

Baker & Keramidas, 2013

• DIRE

CT ST UDY

• Constipation
• T

e mpe r atur e Inse nsitivity

• HA
• Dizzine ss
• F

atigue

• Mood Change
• Nause a/ Indige stion
• Diar

r he a

• Hair

L

• ss
• Obse ssive thoughts/ c r

avings for food

• T

e mpe r atur e Inse nsitivity

• HA
• Dizzine ss
• F

atigue / De c r e ase s in stamina

• Mood Change (Ir

r itability, de pr e ssion, apathy)

• Musc le Sor

e ne ss/ Re duc e d Coor dination

• Hair

L

• ss
• Basal Me tabolic Rate (BMR)de c r

e ase by 40%

• MINNE

SOT A ST ARVAT ION E XPE RIME NT

Baker & Keramidas, 2013

• Unable to determine

recruited

• 349 Included
• Mean Time w/T2D 8‐

10 Years

• A1c 7.6%
• Medication Use
• Diet Alone 12‐

13%

• Insulin 30‐46%

Hallberg, McKenzie, Williams, et al. Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open‐Label, Non‐ Randomized, Controlled Study. Diabetes Therapy 9, 583–612 (2018)

PHYSICAL INTERVENTION:

• Not defined

NUTRITION INTERVENTION:

• Carb restriction 30g/day

to attain 0.5–3.0 mmol L−1 blood BHB levels (modifications to “personal tolerance” after)

• Protein 1.5g/kg
• Fat intake to satiety
• Supplements

recommended

SUPPORT INTERVENTION:

• Remote monitoring

equipment (Scale, BP cuff, BS & Ketone meter) with

• ngoing contact with

health coach and MD or NP

• Onsite education 1x weekly

x 12 weeks; bi‐weekly x 12 weeks, monthly x 6 months, quarterly year 2

• Peer support group
• Food journal to track

hunger cravings, energy, mood

• Unable to determine

recruited

• 215 Included
• New diagnosis
• A1c 7.7%
• Medication Use
• None

Esposito, et al. (2009) Annals of Internal Medicine, 151: pp 306‐315.

PHYSICAL INTERVENTION:

• Goal of 175

minutes/week (30 min, 6 days a week) NUTRITION INTERVENTION:

• 1500 calories/day

women 1800 calories/day men

• Med Diet: High fat

(>30%); 50% carb

• Low Fat: Low fat (<30%)

SUPPORT INTERVENTION:

• Monthly RD appointments x

1 year; bimonthly appts thereafter (6 appts/yr in f/u)

• Recorded food & activity

journals (including housework, occupational, recreational activity)

2020 RANKING OF DIABE T E S DIE T S BY US NE WS

Source: https://health.usnews.com/best‐diet/best‐diets‐overall

“ME DIT E RRANE AN” DIE T “F AST ” DIE T (WIT H A F OCUS ON F AST ING) “PAL E O” DIE T “L OW- GL YCE MIC” DIE T “KE T O” DIE T

• WE

IGHT CYCL ING

• Change s in:
• Musc le Mass
• Insulin Re sistanc e / Hype rinsuline mia
• HT

N and L ipids

• Gluc ose L

e ve ls

• INCRE

ASE INCIDE NCE OF CARDIAC PROBL E MS

• Inc r

e ase In # Of We ight Cyc ling E pisode s = Highe r Odds Of Poor Car diovasc ular He alth

Rhee, 2017; Byun et al, 2019, D'Souza et al (2020)

Studie s de monstr ate ke to die t r e sulte d in fast, shor t- te r m we ight loss, with fast r e gain.

NUT RIT IONAL INT E RPRE T AT IONS W/ OUT ME DICAL GUIDANCE

KE T O DIE T

Protein 1.5g/kg

ADA

Protein 0.8g/kg

e GF R ME D DIE T

Fat Intake >30%

ADA

Sat Fat Intake <10%

Wha t kind o f inte rpre ta tio ns o f hig h fa t o r ke to die ts ha ve yo u se e n?

Torgerson JS, Sjöström L. (2001). The Swedish Obese Subjects (SOS) study‐‐ rationale and results. Romeo, et al (2012)

• Recruited 8966
• 4047 Included
• Paired Matched Control with WLS Participant
• BMI 40‐42
• Fasting BG 156 mg/dl
• Medication Use 48%

SURGICAL INTERVENTION:

• Fixed or variable banding, vertical banded

gastroplasty, or gastric bypass

USUAL CARE INTERVENTION:

• No limitations on non‐surgical treatment

• Rates Of Remission Vary Based On Type

Of Bypass Performed

• Anatomical Differences (GLP‐

1/Duodenal Mucosal Resurfacing)

• Recommended caloric intake of 900‐

1000 calories w/ long‐term vitamin/supplements

• Tend to be smaller studies, with lower

BMI than “real world” criteria

• Suicide and mental illness struggles

are significantly higher than general population Ne ar ly double the r isk of suic ide c ompar e d to the ge ne r al population Ge ne r ic Calor ic Ne e ds Range 1800- 3200

https:/ / he a lth.g o v/ o ur-wo rk/ fo o d-nutritio n/ 2015-2020-die ta ry- g uide line s/ g uide line s/ a ppe ndix-2/ https:/ / untra ppe d.c o m.a u/ wa rning -o n-we ig ht-lo ss-surg e ry/

5 1 1 5 20 25 30 35 40

Suic ide Ra te s

Pe r 100,000 Patie nt Ye ar s

GP (Ma le ) WL S (Ma le ) GP (F e ma le ) WL S (F e ma le )

19.8 35.1 7.2 15

• RE

VE RSAL :

“A TURNING OR CHANGING TO THE OPPOSITE DIRECTION, AS OF A PROCESS, DISEASE, SYMPTOM, OR STATE”

• RE

MISSION:

“ABATEMENT OR LESSENING IN SEVERITY OF THE

SYMPTOMS OF A DISEASE” Source: Medical Dictionary for the Health Professions and Nursing (2012)

A1C < 6.5% X 1 YE AR WI T HOUT USE OF DI ABE T E S ME DI CAT I ONS A1C < 5.7% X 1 YE AR WI T HOUT USE OF DI ABE T E S ME DI CAT I ONS A1C < 5.7% X 5 YE AR WI T HOUT USE OF DI ABE T E S ME DI CAT I ONS

Buse , e t. a l. (No v. 2009).

PARTIAL: A1C < 6.5% OFF MEDS X 1 YEAR

COMPLETE: A1C < 5.7%

OF F ME DS X 1 YE AR

PROLONGED: A1C < 5.7%

OF F ME DS X 5 YE ARS

A1C < 6.5%

OFF MEDS X 2 MONTHS (STUDY YEAR 1) OFF MEDS X 1 YEAR (STUDY YEAR 2) A1C < 6.5%

OFF MEDS X 1 YEAR

A1C < 6.5%

METFORMIN USE CONTINUED

A1C < 6.5%; < 5.7%

REMAINING MED FREE X 1 YEAR

PARTIAL: A1C < 6.5% OFF MEDS X 1 YEAR

COMPLETE: A1C < 5.7%

OF F ME DS X 1 YE AR

PROLONGED: A1C < 5.7%

OF F ME DS X 5 YE ARS

A1C < 6.5%

OFF MEDS (VARIED TIME LINES)

A1C < 6.5% A1C < 6%

OFF MEDS X 1 YEAR

• YEAR 1: 46% ‐‐‐‐‐‐‐
• YEAR 2: 36% 36%
• YEAR 1: 11.4%
• 1/3 Returned To

Diabetes Status Each Year

• YEAR 1: 14.7%
• YEAR 6: 5%
• YEAR 1: 60% 25%
• YEAR 2: 54%

11% P 6% C

A1C < 6.5%

OFF MEDS X 2 MONTHS (STUDY YEAR 1) OFF MEDS X 1 YEAR (STUDY YEAR 2) A1C < 6.5%

OFF MEDS X 1 YEAR

A1C < 6.5%

METFORMIN USE CONTINUED

A1C < 6.5%; < 5.7%

REMAINING MED FREE X 1 YEAR

Weight Loss >15 KG

• YEAR 1: 24%
• YEAR 2: 11%

(17 PPL)

Remember! Weight Interventions Were Conducted Throughout The Studies

Weight Loss >10%

• YEAR 1: 37%
• YEAR 2: 23%

˜ 5lb difference between control & intervention group Mean Weight

• INITIAL: 116 lb
• YEAR 1: 101 lb
• YEAR 2: 102.5 lb

Co ntro l Gro up Give s Co nte xt

• YEAR 2: 73% (219 out of 303)
• YEAR 15: 30% (35 out of 115)

I mpa ire d F a sting Of 90-110 Or < 90 A1C < 6.5% OR <6%

OFF MEDS X 1 YEAR

Sjöström et al. (2014) JAMA.; Sjöström (2004) NEJM

2,007 WL S Initial 115 vs 641??

50% OF PE OPL E NE E DE D T O BE ON “RE SCUE ” PL AN AT

L E AS T 1 T I ME

SURGI CAL I NT E RVE NT I ON GROUP I NI T I AL : 2,007 YE AR 2: 1,845 YE AR 10: 641 I nte rve ntio n g ro up > 90 DSMT g ro up (Co ntro l) 15* *Re po rte dly DSMT g ro up “re c e ive d no c o unse ling in b e ha vio ra l stra te g ie s fo r c ha ng ing die t a nd a c tivity.”

1.47% 0.14% 0.007%

K a rte r e t a l 2014

122,000

Wha t ha ppe ns in the re a l wo rld? Whe re multiple b a rrie rs e xist to just g e tting g re a t dia b e te s c a re ?

It bodes the question, do these studies support T2D progression, rather than T2D reversal or remission???

Marrif (2016).

Co nside r E xplo ring Why T he y’ re Asking Ab o ut Re missio n (Just Curio sity? Burno ut? Ove rwhe lme d/ F rustra te d By A Co mplic a tio n Or E le va te d Gluc o se L e ve ls?

Weight Stigma is a contributor to

weight gain, chronic stress, higher nutrition intake, lower physical activity, and higher mortality.

Rubino et al. 2020

We ig ht T re nds Ac ro ss All Studie s

Co nside r E xplo ring Why We ig ht L

• ss I

s So I mpo rta nt F

• r T

he m? I s I t Be c a use I t’ s A Me dic a l E xpe c ta tio n Of T he m? I s I t Be c a use T he y Wa nt T

• Ma na g e Dia b e te s We ll? Are T

he y Ope n T

• E

xplo ring Wa ys T

• Ma na g e Dia b e te s We ll Witho ut F

ixa ting On We ig ht L

• ss? Do T

he y Unde rsta nd the Risks o f Ba ria tric Surg e ry?

Morgan et al. 2019 Levine et al, 2020 Gaskin et al, 2014

Ho lme s-T rusc o tt, e t a l. 2020

25,000 x 15 ye a rs Po st Ba ria tric Surg e ry

• 2-3x hig he r c ha nc e o f

se e king me dic a l a tte ntio n fo r a me nta l he a lth diso rde r

• 5x inc re a se in E

R visits fo r se lf-ha rm b e ha vio rs

• 10% po st o p de a ths we re

suic ide

• 40% ha d no histo ry o f

me nta l illne ss prio r to

• pe ra tio n

Co st o f He a lthc a re & Supplie s

• 90 x $150/ a ppt = $13,500
• Co st o f lo st wo rk ho urs?
• Supple me nts—I

de a l Pro te in $450/ mo nth - $2700/ 6 mo nths

• Gym me mb e rship/ wo rk o ut

e q uipme nt $50/ mo nth - $600/ ye a r o r mo re

So c ia l/ E nviro nme nta l Re so urc e s

• Appro xima te ly 1/ 3 o f US

a dults do no t ha ve a PCP

• Dia b e te s ra te s ha ve a n

inve rse re la tio nship to po ve rty

• MI

L E S-2 study

• Se lf-e ste e m & so c ia l

suppo rt lo we re d dia b e te s stig ma -b a se d impa c t o f de pre ssio n/ a nxie ty & dia b e te s distre ss

Wha t Ab o ut Re missio n Appe a ls to T he m? I s the Go a l to Re duc e Me dic a tio n Use ? T

• Re duc e Risks o f Co mplic a tio ns? Ho w Ha s Dia b e te s I

mpa c te d the ir L ife -

• -a nd Will the SE

/ inte nsity o f I nte rve ntio ns Be E q uiva le nt to this I mpa c t? Or Wo uld I nte rve ntio ns Be L ike ly to Re so lve Dia b e te s I mpa c ts? Ho w Will the y Ga ug e Suc c e ss—a nd Wha t is T he ir Ba c k Up Pla n I f T he y Do n’ t Se e T his Suc c e ss?