TABLE 1.

Descriptive characteristics, and changes over time in the sham–balloon group and balloon–balloon group

		Sham–Balloon	Balloon–Balloon	p‐value
Baseline T0	Number (male/female)	11 (0/11)	7 (1/6)
	Age	43 [39–47]	42 [3055]	ns
	Body weight kg	113.7 [97.9–119.3]	115.9 [101.5–123.8]	ns
	BMI (kg/m2)	39.2 [35.7–43.1]	42.6 [38.4–43.8]	ns
	Excess weight (%)	180 [15,564–196]	190 [169–200]	ns
	Gastrin mcg/L	0.02 [0.02–0.03]	0.02 [0.02–0.04]	ns
	Insulin mE/L	17 [12–30]	18 [11–56]	ns
	Preprandial/fasting ghrelin a (pg/mL)	670 [625–922]	654 [638–941814]	ns
	AUC ghrelin	49,820 [47,801–62,582]	43,998 [42,898–51,852]	ns
	Number of ghrelin cells/surface area	110.6 [83.6–118.9]	111.7 [84.8–189.0]	ns
13 weeks T1	Body weight kg	100.8 [91.0–109.9]	103.0 [88.3–107.4]	ns
	BMI (kg/m2)	35.4 [31.8–40.8]	37.5 [34.4–42.0]	ns
	Excess weight (%)	160 [145–180]	169 [151–184]	ns
	Weight loss kg first 13 weeks	−11.2 [−12.6 to −7.5]	−13.2 [−17.6 to −8.1]	ns
	Gastrin mcg/L	0.03 [0.02–0.04]	0.02 [0.02–0.04]	ns
	Insulin mE/L	14 [10–18]	15 [11–32]	ns
	Preprandial/fasting Ghrelin a (pg/mL)	765 [573–1,107,830]	691 [598,608–1019]	ns
	AUC ghrelin	53,231 [45,339–58,247]	52,521 [44,243–64,767]	ns
	Number of ghrelin cells/surface area	160.2 [128.5–223.0]	137.3 [63.1–173.3]	ns
26 weeks T2	Body weight kg	89.0 [83.5–102.0]	98.0 [87.4–100.2]	ns
	BMI (kg/m2)	32.6 [30.0–37.8]	36.0 [32.1–39.4]	ns
	Excess weight (%)	146 [136–166]	160 [142–171]	ns
	Weight loss kg week 13–26	−6.90 [−10.8 to −5.2]	−5.0 [−7.2 to +3.1]	0.027
	Weight loss kg overall after 26 weeks	−18.3 [−22.7 to −14.7]	−17.9 [−23.8 to −0.50]	ns
	Gastrin mcg/L	0.02 [0.02–0.03]	0.02 [0.02–0.06]	ns
	Insulin mE/L	13 [9–17]	15 [9–24]	ns
	Preprandial/fasting Ghrelin a (pg/mL)	822 [573,656–931,870]	763 [588–857]	ns
	AUC ghrelin	59,363 [45,442–65,868]	54,939 [42,632–63,670]	ns
	Number of ghrelin cells/surface area	116.3 [91.7–146.9]	102.6 [77.1–136.3]	ns

Note: Values are given as median and interquartile ranges.

^a15 min before presenting the meal.