Effects of Acute Intermittent Hypoxia (AIH) on Metabolism and Dysglycemia, in Overweight/Obese Persons With Spinal Cord Injuries (SCI)
Phase: NA
Conditions: Spinal Cord Injuries, Obesity, Insulin Resistance
Sponsor: University of Miami

 
 
 
 Eff ects of Ac ut e I nt er mitt e nt H y p oxi a 
( AI H) o n M et a b olis m, D ys gl yc e mi a, a n d 
S u bstr at e P artiti o ni n g d uri n g Ex ercis e 
e Pr ost N u m b er: 2 0 1 6 0 8 1 8  
V ersi o n D at e:  S e pt e m b er 1, 2 0 1 7  
V ersi o n N u m b er:  0. 0 5  
P ri nci p al I n v esti g at or N a m e: Dr. M ar k N as h  
N C T N u m b er: N C T 0 2 9 7 3 4 3 8  

P a g e 5  of 1 1  
 
j. a n y fail ure of t he testi n g or rec or di n g e q ui p me nt.  
 
Wit h o ut nee d f or a d diti o nal data c ollecti o n we will calc ulate resti n g a n d w h ole b o d y fat o xi dati o n fr o m ve ntilat or 
data. T otal e ner g y e x pe n dit ure ( T E E), a n d w h ole b o d y car b o h y drate ( C H 2O), a n d fat o xi dati o n rates will be calc ulate d 
usi n g t he f oll o wi n g st oic hi o metric e q uati o ns ass u mi n g ne gli gi ble uri n ar y nitr o ge n e xcreti o n rates: 
 
T E E ( kc al/ mi n)  = 3. 9 V C O 2/ R E R + 1. 1 1 V C O2 
C H 2O o xi d ati o n ( g/ mi n)  = 4. 5 5 V C O 2 – 3. 2 1 9 V O 2 
F at o xi d ati o n ( g/ mi n)  = 1. 6 7 V O 2 – 1. 6 7 V C O 2 
 
w here V C O 2 is t he rate of car b o n di o xi de pr o d uce d i n L/ mi n, R E R is t he res pirat or y e xc ha n ge rati o ( V C O2/ V O2), a n d 
V O 2 is t he rate of o x y ge n c o ns u me d i n L/ mi n. Rates of w h ole b o d y C H2O a n d fat o xi dati o n will be c o n verte d t o 
wei g ht relati ve u nits ( μ m ol/ k g· mi n) usi n g t he m olec ular wei g hts of gl uc ose ( 1 8 0 g/ m ol) a n d a re prese ntati ve T G ( 8 6 0 
g/ m ol). Fat o xi dati o n will be c o n verte d t o fatt y aci d o xi dati o n b y m ulti pl yi n g b y 3 ( 3 m ol fatt y aci ds/ m ol T G).  
 
Rati n gs of percei ve d e xerti o n ( R P E) will be assesse d usi n g t he Cate g or ical-Rati o ( 1 - 1 0) scale of B or g. S u bjects will 
be s h o w n a la mi nate d s heet c o ntai ni n g descri pt ors of t heir percei ve d eff ort ra n gi n g fr o m ‘ n ot hi n g at all’ ( 0) t o ver y, 
ver y har d ( Ma xi mal = 1 0). S u bj ects will state t he n u m ber t hat c orres p o n ds t o t heir perce pti o n of t he diffic ult y of t heir 
tas k wit h s pecific res pect t o: a) t heir ar ms a n d b) t heir eff ort of res pirati o n. 
 
Bl o o d press ure will be meas ure d b y a cali brate d a m b ulat or y press ure m o nit or ( A & D E n gi neeri n g, I nc.) place d o n t he 
d o mi na nt ar m. 
 
F or deter mi nati o n of lactate c o nce ntrati o n, ca pillar y bl o o d will be sa m ple d fr o m t he earl o be i n t he last 1 5 sec o n ds of 
eac h 3 mi n ute sta ge as well as 1, 3, 5 a n d 1 0 mi n utes after cessati o n of e xercise. T he earl o be will be pre pare d usi n g 
alc o h ol s wa bs  a n d will t he n be p u nct ure d wit h a la ncet. Sa m ples will be a nal yze d i m me diatel y usi n g a precali brate d 
a nal yzer ( Lactate Pl us, N o va Bi o me dical, Walt ha m, M A)  
 
3.  Partici pa nts will be ra n d o ml y assi g ne d ( b y t he fli p of a c oi n) t o recei ve b ot h AI H or S H A M i nter ve nti o n a n d t he n t he 
alter nate  i nter ve nti o n  n o  less  t ha n  3  wee ks  later .   T he  or der  of  treat me nt  will  be  ra n d o ml y  assi g ne d  a n d  
c o u nter bala nce d. Partici pa nts will  be bli n de d t o t he i nter ve nti o n t he y are recei vi n g.  I nter ve nti o n or der will be st ore d 
i n a pass w or d pr otecte d d oc u me nt. 
 
Partici pa nts will recei ve i nter mitte nt e x p os ure t o m o derate h y p o xia ( AI H) ( H Y P -1 2 3; H y p o xic o I nc, Ne w Y or k, N Y) 
u n der resti n g c o n diti o ns.  I H treat me nt will ta ke place o ver a peri o d of 4 c o nsec uti ve da ys i n v ol vi n g dail y ( M o n da y-
Fri da y,) h o ur l o n g sessi o ns of alter nati n g 6 -mi n ute h y p o xic i nter vals ( FI O 2 = 0. 0 9 -0. 1 2) wit h 3 -mi n ute n or m o xic 
i nter vals ( FI O 2 = 0. 2 1).  D uri n g h y p o xic i nter vals, o x y ge n c o nce ntrati o n ma y be a dj uste d t o mai ntai n partici pa nts 
S p O 2 le vels bet wee n 7 5- 9 0 % (as pre vi o usl y descri be d i n I R B a p pr o ve d pr ot oc ol # 2 0 1 5 0 1 1 7).  S H A M pr ot oc ol will 
be t he sa me as descri be d a b o ve wit h FI O 2 = 0. 2 1 at all ti mes.  
 
Bl o o d o x y ge n c o nce n trati o n ( S p O 2) will be c o nti n u o usl y m o nit ore d wit h a p ulse o xi meter t o e ns ure t hat partici pa nts 
d o n ot fall bel o w 7 5 %.  T he f oll o wi n g will als o be m o nit ore d d uri n g a n d after h y p o xia treat me nts: hea dac hes, pai n, 
li g ht hea de d ness, dizzi ness, altere d visi o n, res pirat or y distress, c ya n osis, s pas ms, a ut o n o mic d ysrefle xia or c ha n ge i n 
f u ncti o n.   
 
4.  O n da y 1 a n d da y 4 of eac h treat me nt series, s u bjects will u n der g o a faste d O G T T (as descri be d bel o w # 5.).  O n da y 
1, t he O G T T will be perf or me d bef ore t he treat me nt a n d  o n da y 4 it will be perf or me d after t he treat me nt.   Eac h 
treat me nt series will be f oll o we d b y a re peat of t he gra de d e xercise tests wit hi n 2 4 h o urs of t he fi nal e x p os ure sessi o n 
as descri be d i n Secti o n 1 0. 3 of t his d oc u me nt.