Type Two Diabetes MellitusLeptinNCT01207934
Recombinant Human Leptin Therapy Effects on Insulin Action
A study testing low-dose leptin and high-dose leptin in people with Type Two Diabetes Mellitus, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has effects on insulin action in obese subjects with type 2 diabetes… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type Two Diabetes Mellitus
- What is being tested?
- low-dose leptin and high-dose leptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to Jul 2000
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with type 2 diabetes for less than ten years
- Body mass index 25 - 40
- hemoglobin A1C 7.5% - 12.0%
- fasting blood glucose between 90 and 240mg/dL
Who cannot join
- smoking
- pregnancy
- diabetes medications
- regular exercise (more than 3 hours per week)
- uncontrolled hypertension: systolic blood pressure greater than 160 or diastolic blood pressure greater than 95
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.
Read the detailed description
Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has weight loss-independent effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo (saline), low-dose (30 mg/d), or high-dose (80 mg/d) recombinant methionyl human (r-met hu) leptin for 14 days. Multi-organ insulin sensitivity before and after treatment was evaluated by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopically labelled tracer infusions to measure glucose, glycerol and fatty acid kinetics.
- Conditions
- Type Two Diabetes Mellitus
- Being tested
- placebo, low-dose leptin, high-dose leptin
- Keywords
- diabetes, obesity
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary supplement
saline placebo
low-dose leptinDrug
30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
high-dose leptinDrug
80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | saline placebo for fourteen days Receives: Dietary Supplement: placebo |
| low-dose leptin | Experimental | 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days Receives: Drug: low-dose leptin |
| high-dose leptin | Experimental | 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days Receives: Drug: high-dose leptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.
pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.
Measured: baseline
Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.
This is a measure of the body's ability to metabolize sugar after treatment with either leptin or a placebo. We compare the effect of leptin therapy on insulin-mediated stimulation of glucose disposal with that of placebo. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.
Measured: fourteen days
Secondary outcomes (2)
Baseline Plasma Leptin Concentrations
Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood.
Measured: baseline
Post-treatment Plasma Leptin Levels
plasma leptin levels after fourteen days ingestion of either leptin or placebo.
Measured: fourteen days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startAug 1998
- Primary completionJul 2000
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type Two Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207934
- Sponsor's protocol ID
- 98-0643
- Acronym
- Leptin
- Status last verified
- Jun 2015
- First submitted
- 21 Sep 2010
- Last updated
- 9 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mittendorfer B, Horowitz JF, DePaoli AM, McCamish MA, Patterson BW, Klein S. Recombinant human leptin treatment does not improve insulin action in obese subjects with type 2 diabetes. Diabetes. 2011 May;60(5):1474-7. doi: 10.2337/db10-1302. Epub 2011 Mar 16.
PubMed 21411512
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Leptin Therapy Effects on Insulin Action
- ClinicalTrials.gov ID
- NCT01207934
- Acronym / sponsor ID
- Leptin / 98-0643
- Conditions
- Type Two Diabetes Mellitus
- Keywords
- diabetes, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Amgen, National Institutes of Health (NIH)
- Study start
- Aug 1998
- Primary completion
- Jul 2000 (actual)
- Study completion
- Jul 2000 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Posted 10 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.
Detailed description
Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has weight loss-independent effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo (saline), low-dose (30 mg/d), or high-dose (80 mg/d) recombinant methionyl human (r-met hu) leptin for 14 days. Multi-organ insulin sensitivity before and after treatment was evaluated by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopically labelled tracer infusions to measure glucose, glycerol and fatty acid kinetics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: placebosaline placebo for fourteen days |
| low-dose leptin | Experimental | Drug: low-dose leptin30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days |
| high-dose leptin | Experimental | Drug: high-dose leptin80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with type 2 diabetes for less than ten years
- Body mass index 25 - 40
- hemoglobin A1C 7.5% - 12.0%
- fasting blood glucose between 90 and 240mg/dL
Key exclusion criteria (5 listed)
- smoking
- pregnancy
- diabetes medications
- regular exercise (more than 3 hours per week)
- uncontrolled hypertension: systolic blood pressure greater than 160 or diastolic blood pressure greater than 95
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebosaline placebo | Dietary supplement | placebo |
| low-dose leptin30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days | Drug | low-dose leptin |
| high-dose leptin80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days | Drug | high-dose leptin |
Primary outcome
Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.
Time frame: baseline
pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.
Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.
Time frame: fourteen days
This is a measure of the body's ability to metabolize sugar after treatment with either leptin or a placebo. We compare the effect of leptin therapy on insulin-mediated stimulation of glucose disposal with that of placebo. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.
2 secondary outcomes
Baseline Plasma Leptin Concentrations
Time frame: baseline
Post-treatment Plasma Leptin Levels
Time frame: fourteen days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21411512Mittendorfer B, Horowitz JF, DePaoli AM, McCamish MA, Patterson BW, Klein S. Recombinant human leptin treatment does not improve insulin action in obese subjects with type 2 diabetes. Diabetes. 2011 May;60(5):1474-7. doi: 10.2337/db10-1302. Epub 2011 Mar 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-dose leptin and high-dose leptin in people with Type Two Diabetes Mellitus, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars. (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01207934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015; AzTrials last refreshed its copy on 31 Oct 2026.