Insulin ResistanceNCT00457938
Novel Therapies for Metabolic Complications of Lipodystrophies
A study testing low-fat diet ( Still recruiting ) and Diet in people with Insulin Resistance and Hypertriglyceridemia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Lipodystrophies represent a therapeutic challenge with regards to the management of the diabetes, insulin resistance, hypertriglyceridemia and fatty liver which frequently present in conjunction with significant adipose tissue loss. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Insulin Resistance, Hypertriglyceridemia, Diabetes
- What is being tested?
- low-fat diet ( Still recruiting ) and Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- General Inclusion criteria:
- Patients with lipodystrophies as diagnosed by clinical criteria
- Any one of the following:
- Diabetes mellitus, or
- Fasting serum triglycerides greater than 200 mg/dL, or
- Fasting serum insulin greater than 30 U/mL, or
- Hepatic steatosis ( greater than 5.6% hepatic triglyceride content) as demonstrated by 1H MRS.
Who cannot join
- Known liver disease due to causes other than non-alcoholic steatohepatitis:
- Current alcohol abuse (more than 7 drinks or 210 g per wk for women and more than 14 drinks or 420 g per wk for men).
- Positive serological markers of hepatitis B and C.
- Autoimmune hepatitis, autoimmune cholestatic liver disorders, Wilson disease and Alpha-1-antitrypsin deficiency as indicated by clinical and laboratory tests.
- Drug-induced liver disease
- Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study suggestive of liver cancer.
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- Decompensated liver disease as evidenced by clinical features of hepatic failure (variceal bleeding, ascites, hepatic encephalopathy etc.) and laboratory investigations (prolonged prothrombin time, hypoalbuminemia, presence of esophageal varices etc.)
- Use of the drugs which can potentially decrease hepatic steatosis during previous 3 months; high-dose vitamin E, betaine, acetylcysteine, choline and probucol.
- Significant systemic or major illnesses other than liver disease (congestive heart failure, unstable angina, cerebrovascular disease, respiratory failure, renal failure [serum creatinine more then 2 mg/dL], acute pancreatitis, organ transplantation, serious psychiatric disease, and malignancy) that could interfere with the trial and adequate follow up.
- Acute medical illnesses precluding participation in the studies.
- Known HIV infected patient.
- Current substance abuse.
- Pregnant or lactating women.
- Hematocrit of less than 30%.
- History of weight loss ( more than 10%) or use of weight loss drugs such as sibutramine or orlistat in the last 3 months.
- Each subproject has additional specific inclusion and exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Therapies for Metabolic Complications in Patients With Lipodystrophies
Lipodystrophies represent a therapeutic challenge with regards to the management of the diabetes, insulin resistance, hypertriglyceridemia and fatty liver which frequently present in conjunction with significant adipose tissue loss. The purpose of the study and it's four subprojects is to examine the safety and efficacy of various novel interventions designed to improve or resolve the fatty liver, hypertriglyceridemia, and insulin resistance or diabetes that is seen in these patients.
Read the detailed description
We propose novel therapeutic approaches for the management of metabolic complications in patients with lipodystrophies. The four interventions to be tested are:
Hypothesis 1: An extremely low fat diet.
- Conditions
- Insulin Resistance, Hypertriglyceridemia, Diabetes, Hepatic Steatosis
- Being tested
- low-fat diet ( Still recruiting ), Diet
- Keywords
- lipodystrophy
- Medical subject headings
- Insulin Resistance, Hypertriglyceridemia, Diabetes Mellitus, Fatty Liver, Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-fat diet ( Still recruiting )Other
Also called Low fat versus extremely low fat Diet
This study will compare 10% fat versus 35% fat diets in terms if effect on liver fat, triglycerides adn other metabolic parameters.
DietOther
10 % versus 35 % fat in diet
| Study group | Role | What they receive |
|---|---|---|
| Low fat diet is the "drug" | Other | Diet 10% fat versus 35% fat Receives: Other: low-fat diet ( Still recruiting ); Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Project specific: improvement in serum triglycerides, insulin resistance, liver triglyceride content, liver volume, Hgb A1c,
Measured: 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startApr 2006
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Takeda, Amylin Pharmaceuticals, LLC.
- Responsible party
- Principal investigator, Abhimanyu Garg, University of Texas Southwestern Medical Center
- Investigators
- Abhimanyu Garg, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457938
- Sponsor's protocol ID
- RO1-074959
- Other IDs
- DK074959
- Status last verified
- Oct 2018
- First submitted
- 4 Apr 2007
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Simha V, Subramanyam L, Szczepaniak L, Quittner C, Adams-Huet B, Snell P, Garg A. Comparison of efficacy and safety of leptin replacement therapy in moderately and severely hypoleptinemic patients with familial partial lipodystrophy of the Dunnigan variety. J Clin Endocrinol Metab. 2012 Mar;97(3):785-92. doi: 10.1210/jc.2011-2229. Epub 2011 Dec 14.
PubMed 22170723
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Therapies for Metabolic Complications in Patients With Lipodystrophies
- ClinicalTrials.gov ID
- NCT00457938
- Acronym / sponsor ID
- RO1-074959
- Conditions
- Insulin Resistance, Hypertriglyceridemia, Diabetes, Hepatic Steatosis
- Keywords
- lipodystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Takeda, Amylin Pharmaceuticals, LLC.
- Study start
- Apr 2006
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lipodystrophies represent a therapeutic challenge with regards to the management of the diabetes, insulin resistance, hypertriglyceridemia and fatty liver which frequently present in conjunction with significant adipose tissue loss. The purpose of the study and it's four subprojects is to examine the safety and efficacy of various novel interventions designed to improve or resolve the fatty liver, hypertriglyceridemia, and insulin resistance or diabetes that is seen in these patients.
Detailed description
We propose novel therapeutic approaches for the management of metabolic complications in patients with lipodystrophies. The four interventions to be tested are:
Hypothesis 1: An extremely low fat diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low fat diet is the "drug" | Other | Other: low-fat diet ( Still recruiting ), Other: DietDiet 10% fat versus 35% fat |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with lipodystrophies as diagnosed by clinical criteria
- Any one of the following:
Key exclusion criteria (16 listed)
- Known liver disease due to causes other than non-alcoholic steatohepatitis:
- Current alcohol abuse (more than 7 drinks or 210 g per wk for women and more than 14 drinks or 420 g per wk for men).
- Positive serological markers of hepatitis B and C.
- Autoimmune hepatitis, autoimmune cholestatic liver disorders, Wilson disease and Alpha-1-antitrypsin deficiency as indicated by clinical and laboratory tests.
- Drug-induced liver disease
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 |
|---|---|---|
| low-fat diet ( Still recruiting )Also: Low fat versus extremely low fat DietThis study will compare 10% fat versus 35% fat diets in terms if effect on liver fat, triglycerides adn other metabolic parameters. | Other | Low fat diet is the "drug" |
| Diet10 % versus 35 % fat in diet | Other | Low fat diet is the "drug" |
Primary outcome
Project specific: improvement in serum triglycerides, insulin resistance, liver triglyceride content, liver volume, Hgb A1c,
Time frame: 6 to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Derived from this study: PubMed 22170723Simha V, Subramanyam L, Szczepaniak L, Quittner C, Adams-Huet B, Snell P, Garg A. Comparison of efficacy and safety of leptin replacement therapy in moderately and severely hypoleptinemic patients with familial partial lipodystrophy of the Dunnigan variety. J Clin Endocrinol Metab. 2012 Mar;97(3):785-92. doi: 10.1210/jc.2011-2229. Epub 2011 Dec 14.
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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.
Abhimanyu Garg, MD principal investigator
University of Texas Southwestern Medical Center
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-fat diet ( Still recruiting ) and Diet in people with Insulin Resistance and Hypertriglyceridemia, run by University of Texas Southwestern Medical Center 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 7 inclusion and 16 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 16 Oct 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Project specific: improvement in serum triglycerides, insulin resistance, liver triglyceride content, liver volume, Hgb A1c, (time frame: 6 to 12 months). 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 NCT00457938, 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 16 Oct 2018.