Pilot clinical study of an endoscopic, removable duodenal-jejunal bypass liner for the treatment of type 2 diabetes.
BACKGROUND
Bariatric surgery is associated with the rapid improvement of type 2 diabetes (T2DM). Here we report an exploratory trial of a completely endoscopic, removable, duodenal-jejunal bypass liner (DJBL) intended to treat T2DM.


METHODS
Obese T2DM subjects were randomized to receive a DJBL (n = 12) or sham endoscopy (n = 6) in a 24-week study, extended up to 52 weeks. Measurements included weights, hemoglobin A1c (HbA(1c)), meal tolerance testing, fasting glucose, and seven-point glucose profiles. Subjects' diets were adjusted in the first 2 weeks to obtain similar weight loss during this period.


RESULTS
Subjects had baseline HbA(1c) of 9.1 +/- 1.7% and body mass index of 38.9 +/- 6.1 kg/m(2) (+/- SD). In the completer population by week 1, change in fasting glucose in the DJBL arm was -55 +/- 21 mg/dL versus +42 +/- 30 mg/dL in the sham arm (P < or = 0.05; +/- SE); the seven-point glucose profiles were reduced in the DJBL arm but not in the sham arm. Mean postprandial glucose area under the curve was reduced in the DJBL arm by 20% and increased 17% in the sham arm (P = 0.016). At week 12, HbA(1c) change was -1.3 +/- 0.9% in the DJBL arm and -0.7 +/- 0.4% in the sham arm (P > 0.05), and at 24 weeks, values were -2.4 +/- 0.7% in the DJBL arm and -0.8 +/- 0.4% in the sham arm (P > 0.05). Device migrations required endoscopic removal prior to reaching 52 weeks.


CONCLUSIONS
The DJBL rapidly normalized glycemic control in obese T2DM subjects, a promising development in the search for novel therapies less invasive than bariatric surgery.
Rodriguez
Leonardo
L
Centro de Cirugía de la Obesidad, Hospital Dipreca, Las Condes, Santiago de Chile, Chile.
Reyes
Eliana
E
Fagalde
Pilar
P
Oltra
Maria Soledad
MS
Saba
Jorge
J
Aylwin
Carmen Gloria
CG
Prieto
Carolina
C
Ramos
Almino
A
Galvao
Manoel
M
Gersin
Keith S
KS
Sorli
Christopher
C
D000328:Adult; D050110:Bariatric Surgery / Q000295:instrumentation*; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000378:metabolism / Q000601:surgery*; D004724:Endoscopy; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000378:metabolism / Q000601:surgery*; D018579:Patient Selection; D010865:Pilot Projects; D016896:Treatment Outcome
D001786:Blood Glucose