Trial Outcomes & Findings for Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs) (NCT NCT00706381)

NCT ID: NCT00706381

Last Updated: 2020-07-22

Results Overview

Energy expenditure is measured over 6 hours in a respiratory chamber for each intervention and placebo.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

31 participants

Primary outcome timeframe

6 hours

Results posted on

2020-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	1: Carb Meal, Fat Meal, Sincalide, Placebo, Urso Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, and IV placebo + PO Ursodiol 15mg/kg day 5	2: Fat Meal, Carb Meal, Sincalide, Placebo, Urso Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5	3: Carb Meal, Fat Meal, Placebo, Sincalide, Urso Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5	4: Fat Meal, Carb Meal, Placebo, Sincalide, Urso Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, the IV placebo + PO Ursodiol 15mg/kg day 5
Overall Study STARTED	10	6	6	9
Overall Study Intervention 1 (1 Day)	10	6	6	9
Overall Study Intervention 2 (1 Day)	10	6	6	9
Overall Study Intervention 3 (1 Day)	10	6	6	9
Overall Study Intervention 4 (1 Day)	10	5	6	9
Overall Study Intervention 5 (1 Day)	10	5	5	9
Overall Study COMPLETED	10	5	5	9
Overall Study NOT COMPLETED	0	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	1: Carb Meal, Fat Meal, Sincalide, Placebo, Urso Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, and IV placebo + PO Ursodiol 15mg/kg day 5	2: Fat Meal, Carb Meal, Sincalide, Placebo, Urso Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5	3: Carb Meal, Fat Meal, Placebo, Sincalide, Urso Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5	4: Fat Meal, Carb Meal, Placebo, Sincalide, Urso Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, the IV placebo + PO Ursodiol 15mg/kg day 5
Overall Study Lost to Follow-up	0	1	1	0

Baseline Characteristics

Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1: Carb Meal, Fat Meal, Sincalide, Placebo, Urso n=10 Participants Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, and IV placebo + PO Ursodiol 15mg/kg day 5	2: Fat Meal, Carb Meal, Sincalide, Placebo, Urso n=6 Participants Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5	3: Carb Meal, Fat Meal, Placebo, Sincalide, Urso n=6 Participants Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5	4: Fat Meal, Carb Meal, Placebo, Sincalide, Urso n=9 Participants Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, the IV placebo + PO Ursodiol 15mg/kg day 5	Total n=31 Participants Total of all reporting groups
Age, Continuous	30.8 years n=5 Participants	32.3 years n=7 Participants	33.4 years n=5 Participants	30.4 years n=4 Participants	31.6 years n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	15 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	16 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	27 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	20 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: All participants were to participate in all interventions via cross-over design. One patient did not complete the placebo portion and so was eliminated from analysis in all groups. One other participant did not complete the ursodiol portion.

Energy expenditure is measured over 6 hours in a respiratory chamber for each intervention and placebo.

Outcome measures

Outcome measures
Measure	Carb Meal n=30 Participants All participants who completed the carbohydrate meal and placebo portions of the study	Fat Meal n=30 Participants All participants who completed the high fat meal and placebo portions of the study	Sincalide n=30 Participants All participants who completed the sincalide and placebo portions of the study	Ursodiol n=29 Participants All participants who completed the ursodiol and placebo portions of the study	Placebo n=30 Participants All participants who completed the sincalide portion of the study
Energy Expenditure	1.37 kcal/min Standard Deviation 0.11	1.40 kcal/min Standard Deviation 0.09	1.28 kcal/min Standard Deviation 0.06	1.27 kcal/min Standard Deviation 0.05	1.28 kcal/min Standard Deviation 0.05

PRIMARY outcome

Timeframe: 6 hours

Bile acid is measured at 0, 60, 90 and 360 minutes during a 6 hour stay in in a respiratory chamber for each intervention and placebo. The mean of these 4 values is then calculated.