A novel intragastric balloon for treatment of obesity and type 2 diabetes. A two-center pilot trial

Figures & data

Figure 1. The balloon is contained in a capsule which can be swallowed by the patient.

Figure 2. The balloon is filled through a catheter which can subsequently be dislodged. A self-opening valve will empty the balloon after 16 weeks.

Table 1. Exclusion criteria.

Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease

Previous bariatric or gastric surgery

History of chronic or acute pancreatitis, small bowel obstructions or open abdominal or pelvic surgery

Thyroid or adrenal disease not controlled with medication

History, signs or symptoms of esophageal, gastric, or duodenal disease including dysphagia, hiatal hernias > 5 centimeters, paraesophageal hernias, chronic or acute inflammation, cancer, varices, diverticula, gastroparesis, ulcers, strictures, or achalasia

Genetic or hormonal syndromes such as Prader-Willi syndrome

Severe coagulopathy, hepatic insufficiency, or cirrhosis

Inability to discontinue use of aspirin or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to balloon deployment to 14 days after balloon excretion.

Anemia (Hgb <11 g/dl for females and <12 g/dl for males)

Inability to walk 200 meters without assistance

Eating disorders including night eating syndrome, bulimia, and binge eating disorder

Current or history of illicit drug use or excessive alcohol use

Current use of the following medications within 30 days prior to enrolment, or anticipated need for these medications during the study: Systemic corticosteroids; anticoagulants or anti-platelet therapy; opiates or opioids; antiepileptic drugs

Serum autoantibodies against glutamic acid decarboxylase or tyrosine phosphatase

Any specified conditions that, in the opinion of the investigator, may render the subject unable to complete the study without a likely fatal outcome, or lead to difficulties for subject compliance with study requirements, or could confound study data

Pregnancy and breast-feeding

Table 2. Patient characteristics.

	Oslo University Hospital	Vestfold Hospital	Overall
	n = 10	n = 9	n = 19
Gender: n (%)
Male	7 (70)	7 (78)	14 (74)
Female	3 (30)	2 (22)	5 (26)
Age (years): mean (range)	43 (35–48)	47 (27–65)	45 (27–65)
Weight (kg): mean (SD)	112.7 (15.6)	113.3 (14.7)	113.0 (14.8)
BMI (kg/m^2): mean (SD)	37.3 (2.2)	37.1 (2.5)	37.2 (2.3)
HbA1c (mmol/mol): mean (SD)	51 (9)	69 (17)	60(16)
Comorbidity: n (%)
OSAS	5 (50)	2 (22)	7 (37)
Hypertension	4 (40)	3 (33)	7 (37)
Osteoarthritis	0 (0)	2 (22)	2 (11)

BMI: body mass index; OSAS: obstructive sleep apnea syndrome.

Table 3. Results.

Patient	Before treatment					4 weeks			16 weeks			52 weeks
Oslo University Hospital	BMI	HbA1c	Diabetic	GEBT T1/2	GEBT Tlag	TBWL%	Δ HbA1c	Diabetic	%TBWL	Δ HbA1c	Diabetic	%TBWL	Δ HbA1c	Diabetic
	(SD)	(SD)	Medication	(SD)	(SD)	(95% CI)	(95% CI)	Medication	(95% CI)	(95% CI)	Medication	(95% CI)	(95% CI)	Medication
1	38.4	48	None			2.6	−9	None	5.1	−6	None	−3.7	6	None
2	35.1	60	M, SU, G, S			2.4	−5	M, S	0.1	−4	M, S	7.2	−20	M, S
3	37.5	41	M			3.5	−1	M	4.7	−5	M	MD	MD	MD
4	39.3	43	M			3.1	5	M	6.6	2	M	7.4	−3	M
5	34.2	50	M			4.5	−2	M	4.2	−2	M	−0.5	−1	M
6	38.4	49	M, G			3.0	−6	M, G	2.9	−4	M, G	2.0	0	M, G
7	33.8	50	None			1.9	−5	None	1.7	−4	None	1.7	−2	None
8	39.9	41	M			1.2	−1	M	−2.2	1	M	−8.3	21	M
9	36.6	57	M, D			3.7	−5	M, D	2.0	−7	M, D	MD	MD	MD
10	39.3	70	M, I, G, S			2.0	−10	M, I, G, S	2.1	2	M, I, G, S	−0.2	−1	M, I, G, S
Center mean	37.3	51				2.8	−4		2.7	−3		0.7	0
	(2.2)	(9)				(2.1–3.5)	(−7 to −1)		(0.9–4.6)	(−5 to 0)		(−3.7 to 5.1)	(−9 to 9)
Vestfold Hospital
11	34.0	93	M, I, D, S	96.6	26.5	3.0	−19	M, I, D, S	1.5	MD	M, I, D, S	MD	MD	MD
12	39.2	83	M	238.7	129.0	7.1	−20	M	6.5	−32	M	0.6	−29	M
13	39.9	53	M	80.1	45.8	7.4	−6	M	9.6	−10	M	−0.3	5	M
14	33.0	88	M, I, G	60.6	44.8	5.3	−18	M, I, G	5.6	−11	M, I, G	2.5	−2	M, I, G
15	38.9	66	M, G, S	67.6	35.7	2.0	−10	M, G, S	−0.2	−5	M, G, S	−0.2	26	M, S
16	37.5	79	I	73.3	58.0	2.7	−6	I	4.4	−8	I, G	−1.3	−9	I, G
17	35.7	62	M, I, G, D, S	64.3	46.9	5.7	−5	M, I, G, S	3.1	−5	M, I G, S	−3.9	0	M, I, G, S
18	39.0	46	M, I, G	MD	MD	3.8	−3	M, G	1.7	−13	M, I, G	−3.4	2	M, I, G
19^a	36.5	53	M, S	103.4	85.0	11.0	−12	M, S, G	14.2	0	M, S	13.0	−16	M, S
Center mean	37.1	69		98.1	59.0	5.3	−11		5.1	−11		0.9	−3
	(2.4)	(17)		(58.8)	(31.1)	(3.1–7.5)	(−16 to −6)		(1.7–8.6)	(−19 to −2)		(−3.6 to 5.3)	(−16 to 11)
Study mean	37.2	60				4.0	−7		3.9	−6		0.8	−1
	(2.3)	(16)				(2.8–5.2)	(−10 to −4)		(2.1–5.7)	(−10 to −2)		(1.9 to 3.5)	(−9 to 6)

Results for weeks 4–52 are compared with before treatment. TBWL: total body weight loss; GEBT: gastric emptying breath test only performed by patients recruited at Vestfold Hospital; T_50%: gastric half emptying time; T_lag: lag time; MD: missing data.

^aPatient no. 19 had the balloon endoscopically removed at day 15 due to gastric outlet obstruction. Diabetic medication: M: metformin; SU: sulfonylureas; I: insulin; G: GLP-1 receptor antagonists; D: DPP-4 antagonists; S: SGLT2 inhibitors.