Trial · NCT01778556
Short-term Effects of Leptin in People With Lipodystrophy
NCT01778556, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2019-11-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Short-term Effects of Leptin in People With Lipodystrophy. Trials, record NCT01778556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01778556
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Short-term Effects of Leptin in People With Lipodystrophy
- NCT number
- NCT01778556
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Lipodystrophy
- Interventions
- Metreleptin
- First posted
- 2013-01-29
- Last updated
- 2019-11-13
- Results first posted
- 2019-11-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Body Insulin Sensitivity | Intervention 1 (5 days), Intervention 2 (14 days), and Long-term follow-up (6 months) | Total body insulin sensitivity (measured as glucose disposal rate during a hyperinsulinemic, euglycemic clamp) |
| Secondary | Insulin-mediated Suppression of Hepatic Glucose Production | Intervention 1 (5 days), Intervention 2 (14 days), and Long-term follow-up (6 months) | Hepatic insulin sensitivity (measured as suppression of endogenous glucose production during a hyperinsulinemic, euglycemic clamp) |
| Secondary | Endogenous Rate of Appearance of Palmitate | Intervention 1 (5 days), Intervention 2 (14 days), and Long-term follow-up (6 months) | Endogenous Rate of Appearance of Palmitate is measured in plasma. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Body Insulin Sensitivity | Intervention 1 (5 days), Intervention 2 (14 days), and Long-term follow-up (6 months) | One patient at Period 2 (14 days) in Leptin naive arm was withdrew due to protocol violation. | mg/kg fat-free mass/min | MEAN |
| SECONDARY | Insulin-mediated Suppression of Hepatic Glucose Production | Intervention 1 (5 days), Intervention 2 (14 days), and Long-term follow-up (6 months) | Measurements were not available. | percentage | MEAN |
| SECONDARY | Endogenous Rate of Appearance of Palmitate | Intervention 1 (5 days), Intervention 2 (14 days), and Long-term follow-up (6 months) | Measurements were not available. | μmol/kg fat-free mass/min | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Body Insulin Sensitivity | Leptin Naive | Intervention 1 (5 days) | 4.4 | Standard Deviation 2.3 | mg/kg fat-free mass/min |
| Total Body Insulin Sensitivity | On-leptin | Intervention 1 (5 days) | 10.9 | Standard Deviation 4.1 | mg/kg fat-free mass/min |
| Total Body Insulin Sensitivity | Leptin Naive | Intervention 2 (14 days) | 5.8 | Standard Deviation 2.2 | mg/kg fat-free mass/min |
| Total Body Insulin Sensitivity | On-leptin | Intervention 2 (14 days) | 6.4 | Standard Deviation 1.8 | mg/kg fat-free mass/min |
| Total Body Insulin Sensitivity | Leptin Naive | Long-term follow-up (6 months) | 8.0 | Standard Deviation 4.0 | mg/kg fat-free mass/min |
| Insulin-mediated Suppression of Hepatic Glucose Production | Leptin Naive | Intervention 1 (5 days) | 61.2 | Standard Deviation 23.4 | percentage |
| Insulin-mediated Suppression of Hepatic Glucose Production | On-leptin | Intervention 1 (5 days) | 77.1 | Standard Deviation 42.7 | percentage |
| Insulin-mediated Suppression of Hepatic Glucose Production | Leptin Naive | Intervention 2 (14 days) | 75.2 | Standard Deviation 33.1 | percentage |
| Insulin-mediated Suppression of Hepatic Glucose Production | On-leptin | Intervention 2 (14 days) | 63.8 | Standard Deviation 31.7 | percentage |
| Insulin-mediated Suppression of Hepatic Glucose Production | Leptin Naive | Long-term follow-up (6 months) | 85.6 | Standard Deviation 17.9 | percentage |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Intervention 1 (5 Days) | STARTED | Leptin Naive | 15 | |
| Intervention 1 (5 Days) | STARTED | On-leptin | 10 | |
| Intervention 1 (5 Days) | COMPLETED | Leptin Naive | 15 | |
| Intervention 1 (5 Days) | COMPLETED | On-leptin | 8 | |
| Intervention 1 (5 Days) | NOT COMPLETED | Leptin Naive | 0 | |
| Intervention 1 (5 Days) | NOT COMPLETED | On-leptin | 2 | |
| Intervention 2 (14 Days) | STARTED | Leptin Naive | 15 | |
| Intervention 2 (14 Days) | STARTED | On-leptin | 8 | |
| Intervention 2 (14 Days) | COMPLETED | Leptin Naive | 14 | |
| Intervention 2 (14 Days) | COMPLETED | On-leptin | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events45
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 | decreased appetite | Metabolism and nutrition disorders | Intervention 1 (5 Days) : Leptin Naive | 0 | 15 | 0 |
| other | decreased appetite | Metabolism and nutrition disorders | Intervention 2 (14 Days): Leptin Naive | 0 | 15 | 0 |
| other | decreased appetite | Metabolism and nutrition disorders | Long-term Follow-up (6 Months): Leptin Naive | 1 | 15 | 1 |
| other | decreased appetite | Metabolism and nutrition disorders | Intervention 1 ( 5 Days) : On-Leptin | 8 | ||
| other | decreased appetite | Metabolism and nutrition disorders | Intervention 1 ( 14 Days): On-Leptin | 8 | ||
| other | weight loss | Metabolism and nutrition disorders | Intervention 1 (5 Days) : Leptin Naive | 0 | 15 | 0 |
| other | weight loss | Metabolism and nutrition disorders | Intervention 2 (14 Days): Leptin Naive | 0 | 15 | 0 |
| other | weight loss | Metabolism and nutrition disorders | Long-term Follow-up (6 Months): Leptin Naive | 1 | 15 | 1 |
| other | weight loss | Metabolism and nutrition disorders | Intervention 1 ( 5 Days) : On-Leptin | 8 | ||
| other | weight loss | Metabolism and nutrition disorders | Intervention 1 ( 14 Days): On-Leptin | 8 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention 1 (5 Days) : Leptin Naive | 0 | 15 |
| Total, all-cause mortality | Intervention 2 (14 Days): Leptin Naive | 0 | 15 |
| Total, all-cause mortality | Long-term Follow-up (6 Months): Leptin Naive | 0 | 15 |
| Total, all-cause mortality | Intervention 1 ( 5 Days) : On-Leptin | 0 | 8 |
| Total, all-cause mortality | Intervention 1 ( 14 Days): On-Leptin | 0 | 8 |
| Total, other adverse events | Intervention 1 (5 Days) : Leptin Naive | 0 | 15 |
| Total, other adverse events | Intervention 2 (14 Days): Leptin Naive | 2 | 15 |
| Total, other adverse events | Long-term Follow-up (6 Months): Leptin Naive | 4 | 15 |
| Total, other adverse events | Intervention 1 ( 5 Days) : On-Leptin | 0 | 8 |
| Total, other adverse events | Intervention 1 ( 14 Days): On-Leptin | 0 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers12
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01778556
GET https://conductscience.org/api/trials/v1/NCT01778556/events?page=2