Trial Outcomes & Findings for Acute Effect of Exenatide on Brain Glucose Metabolism (NCT NCT01588418)

Last Updated: 2017-11-24

Results Overview

To study the acute effect of exenatide on brain glucose metabolism after the glucose load. Brain glucose uptake will be determined from serial FDG PET-imaging, by using graphical methods to quantify both global and regional results. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

120 minutes after exenatide or placebo injection

Results posted on

2017-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	OGTT-PET: Exenatide First Then Placebo In the first study subjects received exenatide 5ug injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received placebo injection before OGTT-PET	OGTT-PET: Placebo First, Then Exenatide In the first study subjects received placebo injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received exenatide injection (5ug) before OGTT-PET
Overall Study STARTED	11	4
Overall Study COMPLETED	11	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Effect of Exenatide on Brain Glucose Metabolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PET With Exenatide vs Placebo Injection n=15 Participants All subjects will receive the same intervention with Exenatide and placebo. Exenatide or placebo will be administered in random order, (i.e. first or second before OGTT-PET study). In the first study IGT male subjects will be randomized to exenatide or placebo injection before OGTT-PET study. In the second study the same subjects will receive placebo or exenatide respectively before OGTT-PET study. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
BMI (Body Mass Index)	29 kg/m^2 STANDARD_DEVIATION 3 • n=5 Participants
Fasting plasma glucose	114 mg/dl STANDARD_DEVIATION 3 • n=5 Participants
HbA1c	5.6 % of total hemoglobin STANDARD_DEVIATION 0.1 • n=5 Participants
2 hour plasma glucose concentration	177 mg/dl STANDARD_DEVIATION 11 • n=5 Participants

PRIMARY outcome

Timeframe: 120 minutes after exenatide or placebo injection

Population: We studied, in the same subject, the acute effect of injection of exenatide vs placebo on brain glucose metabolism (CMRglu) after the glucose load. We used FDG PET-imaging to quantify global and regional results.

Outcome measures

Outcome measures
Measure	Effect of Exenatide or Placebo on CMRglu n=15 Participants Brain glucose metabolism (CMRglu) during OGTT measured by PET w/ or w/out Exenatide injection	Placebo First, Then Exenatide Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg . Exenatide: Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study Placebo: Placebo was administered in random order 30 min before OGTT-PET study in the same subject
Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism total gray matter CMRglu after Exenatide	0.14 μmol/(ml*min) Standard Error 0.02	—
Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism total gray matter CMRglu after Placebo	0.10 μmol/(ml*min) Standard Error 0.01	—

SECONDARY outcome

Timeframe: 60 minutes after exenatide or placebo injection

Population: Outcome data was not collected

we evaluated the acute effects of exenatide on hepatic (Hep-IR) and adipose (Adipo-IR) insulin resistance and glucose uptake.

Outcome measures

Outcome data not reported

Adverse Events

PET With Exenatide or Placebo Injection

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

Dr. Ralph DeFronzo

University of Texas Health Science Center at San Antonio

Phone: 210-567-6691

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place