Trial Outcomes & Findings for Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla (NCT NCT00786825)

NCT ID: NCT00786825

Last Updated: 2019-12-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2019-12-18

Participant Flow

Participant milestones

Measure	Somatostatin Type 1 diabetes and Hypoglycemia unawareness somatostatin: Somatostatin may be used to suppress endogenous insulin secretion	Healthy Controls Healthy control subjects
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla

Baseline characteristics by cohort

Measure	Somatostatin n=5 Participants Type 1 diabetes and Hypoglycemia unawareness somatostatin: Somatostatin may be used to suppress endogenous insulin secretion	Healthy Controls n=5 Participants Healthy control subjects	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	57 years STANDARD_DEVIATION 4 • n=93 Participants	57 years STANDARD_DEVIATION 3 • n=4 Participants	57 years STANDARD_DEVIATION 3 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	5 participants n=93 Participants	5 participants n=4 Participants	10 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Measure	Somatostatin n=5 Participants Type 1 diabetes and Hypoglycemia unawareness somatostatin: Somatostatin may be used to suppress endogenous insulin secretion	Healthy Controls n=5 Participants Healthy control subjects
Brain Glycogen Turnover Rate	0.31 mg/kg/min Standard Deviation 0.23	0.28 mg/kg/min Standard Deviation 0.06

Adverse Events

Somatostatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Seaquist, MD

University of Minnesota

Phone: 612-624-9176

Email: seaqu001@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place