Trial · NCT00897676
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
NCT00897676, Phase 1, Phase 2, Completed, Diva De Leon; results first posted 2018-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity. Trials, record NCT00897676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00897676
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
- NCT number
- NCT00897676
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Diva De Leon
- Conditions
- Congenital Hyperinsulinism
- Interventions
- Exendin-(9-39), placebo
- First posted
- 2009-05-12
- Last updated
- 2020-03-13
- Results first posted
- 2018-01-18
- Limitations and caveats
For safety reasons, blood glucose levels were maintained above a safety threshold (55-60mg/dL) during the study by infusing dextrose intravenously which may limit the magnitude of the effect that we will be able to detect.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve (AUC) Plasma Glucose | Time 0 min - time 360 min | Area under the curve plasma glucose from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion |
| Secondary | Area Under the Curve (AUC) Plasma Insulin | time 0 min to time 360 min | Area under the curve plasma insulin from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion |
| Secondary | Area Under the Curve (AUC) Plasma C-peptide | time 0 min to time 360 min | Area under the curve plasma C-peptide from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion |
| Secondary | Area Under the Curve (AUC) Plasma Glucagon | time 0 min to time 360 min | Area under the curve plasma glucagon from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion |
| Secondary | Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1) | time 0 to time 360 min | Area under the curve plasma total GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion |
| Secondary | Area Under the Curve ( AUC) Plasma Active GLP-1 (Glucagon-like Peptide-1) | time 0 min to time 360 min | Area under the curve plasma active GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve (AUC) Plasma Glucose | Time 0 min - time 360 min | A total of 16 subjects were included in the analysis. 1 subject was withdrawn. | mg*min/dL | MEAN |
| SECONDARY | Area Under the Curve (AUC) Plasma Insulin | time 0 min to time 360 min | data from only 15 subjects because the values were below the level of detection for one subject. | uIU*min/mL | MEAN |
| SECONDARY | Area Under the Curve (AUC) Plasma C-peptide | time 0 min to time 360 min | ng*min/mL | MEAN | |
| SECONDARY | Area Under the Curve (AUC) Plasma Glucagon | time 0 min to time 360 min | pg*min/mL | MEAN | |
| SECONDARY | Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1) | time 0 to time 360 min | pmol*min/L | MEAN | |
| SECONDARY | Area Under the Curve ( AUC) Plasma Active GLP-1 (Glucagon-like Peptide-1) | time 0 min to time 360 min | pmol*min/L | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve (AUC) Plasma Glucose | Vehicle | 26994.7 | Standard Deviation 4219.8 | mg*min/dL | |
| Area Under the Curve (AUC) Plasma Glucose | Exendin-(9-39) | 32122.2 | Standard Deviation 6650.1 | mg*min/dL | |
| Area Under the Curve (AUC) Plasma Insulin | Vehicle | 1578.7 | Standard Deviation 1089.9 | uIU*min/mL | |
| Area Under the Curve (AUC) Plasma Insulin | Exendin-(9-39) | 1284.5 | Standard Deviation 553.7 | uIU*min/mL | |
| Area Under the Curve (AUC) Plasma C-peptide | Vehicle | 281.4 | Standard Deviation 155.8 | ng*min/mL | |
| Area Under the Curve (AUC) Plasma C-peptide | Exendin-(9-39) | 236.6 | Standard Deviation 112.5 | ng*min/mL | |
| Area Under the Curve (AUC) Plasma Glucagon | Vehicle | 22806.8 | Standard Deviation 10210.3 | pg*min/mL | |
| Area Under the Curve (AUC) Plasma Glucagon | Exendin-(9-39) | 23409.4 | Standard Deviation 11396.1 | pg*min/mL | |
| Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1) | Vehicle | 4899.3 | Standard Deviation 2598.8 | pmol*min/L | |
| Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1) | Exendin-(9-39) | 5698.8 | Standard Deviation 3484.8 | pmol*min/L |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Intervention 1(6 Hours) | STARTED | Vehicle First Then Exendin-(9-39) | 9 | |
| Intervention 1(6 Hours) | STARTED | Exendin-(9-39) First Then Vehicle | 7 | |
| Intervention 1(6 Hours) | COMPLETED | Vehicle First Then Exendin-(9-39) | 9 | |
| Intervention 1(6 Hours) | COMPLETED | Exendin-(9-39) First Then Vehicle | 7 | |
| Intervention 1(6 Hours) | NOT COMPLETED | Vehicle First Then Exendin-(9-39) | 0 | |
| Intervention 1(6 Hours) | NOT COMPLETED | Exendin-(9-39) First Then Vehicle | 0 | |
| Intervention 2(6 Hours) | STARTED | Vehicle First Then Exendin-(9-39) | 9 | |
| Intervention 2(6 Hours) | STARTED | Exendin-(9-39) First Then Vehicle | 7 | |
| Intervention 2(6 Hours) | COMPLETED | Vehicle First Then Exendin-(9-39) | 9 | |
| Intervention 2(6 Hours) | COMPLETED | Exendin-(9-39) First Then Vehicle | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | hypoglycemia | Endocrine disorders | Vehicle | 11 | 16 | 11 |
| other | hypoglycemia | Endocrine disorders | Exendin-(9-39) | 7 | 16 | 7 |
| other | hyperglycemia | Endocrine disorders | Vehicle | 1 | 16 | 1 |
| other | hyperglycemia | Endocrine disorders | Exendin-(9-39) | 0 | 16 | 0 |
| other | Emesis | Gastrointestinal disorders | Vehicle | 0 | 16 | 0 |
| other | Emesis | Gastrointestinal disorders | Exendin-(9-39) | 1 | 16 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle | 0 | 16 |
| Total, all-cause mortality | Exendin-(9-39) | 0 | 16 |
| Total, other adverse events | Vehicle | 12 | 16 |
| Total, other adverse events | Exendin-(9-39) | 8 | 16 |
| Total, serious adverse events | Vehicle | 0 | 16 |
| Total, serious adverse events | Exendin-(9-39) | 0 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35416981 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Exendin-(9-39) vs Vehicle: deaths from any cause | Trial comparisons |
| Exendin-(9-39) vs Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00897676
GET https://conductscience.org/api/trials/v1/NCT00897676/registered