T2DM (Type 2 Diabetes Mellitus)NCT01373814
Nutritional Therapy for Diabetic Cardiomyopathy
An observational study of T2DM (Type 2 Diabetes Mellitus), run by Washington University School of Medicine at 1 site in United States.
Trial summary
The goal of this study is to determine if nutritional therapy can effectively treat/prevent T2DM and its consequent cardiomyopathy. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2010to 17 Jun 2011
- Phase
- Observational
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known T2DM and who are not taking exogenous insulin.
Who may be able to join
- Subjects must be >30 and <65 years of age, in order to limit the confounding affect of age on our endpoints.
- Subjects must have an ejection fraction >45% (based on their echocardiogram)
- Patients with T2DM and nonalcoholic fatty liver disease or steatohepatitis may be included since they have extensive evidence of steatosis.
Who cannot join
- Subjects who have had a myocardial infarction or resting ischemia (by history or as evidenced by hypo/akinesis on the pre-intervention echocardiogram) will be excluded because hypo/akinesis would affect our endpoints of LV mass and diastolic function.
- Subjects who are unstable, not able to lie flat for the imaging studies, unable to give informed consent, pregnant, lactating, with atrial fibrillation (which would compromise measurement of E'), or current smokers will be excluded.
- Subjects with other major systemic diseases per their clinical charts, history, physical exam, or significant renal insufficiency will also be excluded, as these other system diseases may affect our study endpoints and subject follow-up.
- We will exclude patients with significant LV systolic dysfunction (ejection fraction <45%)
- We will not exclude patients with sleep apnea because it does not detrimentally affect LV diastolic function.
- Subjects will be excluded a priori if they have any history or evidence of liver disease other than NAFLD, consumed >20 g alcohol per day.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The goal of this study is to determine if nutritional therapy can effectively treat/prevent T2DM and its consequent cardiomyopathy.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac function
cardiac function as measured by echocardiography incl. tissue Doppler
Measured: 2 weeks
Secondary outcomes (3)
liver steatosis
liver fat content as measured using MR spectroscopy
Measured: 2 weeks
myocardial steatosis
fat in heart muscle as measured using MR spectroscopy
Measured: 2 weeks
lipidomics
mass spectroscopy measures of plasma lipid species
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study start3 Sep 2010
- Primary completion17 Jun 2011
- Study completion17 Jun 2011
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 T2DM (Type 2 Diabetes Mellitus)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda R Peterson, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373814
- Sponsor's protocol ID
- 10-1163
- Status last verified
- Jan 2024
- First submitted
- 13 Jun 2011
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Airhart S, Cade WT, Jiang H, Coggan AR, Racette SB, Korenblat K, Spearie CA, Waller S, O'Connor R, Bashir A, Ory DS, Schaffer JE, Novak E, Farmer M, Waggoner AD, Davila-Roman VG, Javidan-Nejad C, Peterson LR. A Diet Rich in Medium-Chain Fatty Acids Improves Systolic Function and Alters the Lipidomic Profile in Patients With Type 2 Diabetes: A Pilot Study. J Clin Endocrinol Metab. 2016 Feb;101(2):504-12. doi: 10.1210/jc.2015-3292. Epub 2015 Dec 10.
PubMed 26652763
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Therapy for Diabetic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01373814
- Acronym / sponsor ID
- 10-1163
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 3 Sep 2010
- Primary completion
- 17 Jun 2011 (actual)
- Study completion
- 17 Jun 2011 (actual)
- First posted
- 15 Jun 2011 (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.
The goal of this study is to determine if nutritional therapy can effectively treat/prevent T2DM and its consequent cardiomyopathy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known T2DM and who are not taking exogenous insulin.
Key inclusion criteria (3 listed)
- Subjects must be >30 and <65 years of age, in order to limit the confounding affect of age on our endpoints.
- Subjects must have an ejection fraction >45% (based on their echocardiogram)
- Patients with T2DM and nonalcoholic fatty liver disease or steatohepatitis may be included since they have extensive evidence of steatosis.
Key exclusion criteria (6 listed)
- Subjects who have had a myocardial infarction or resting ischemia (by history or as evidenced by hypo/akinesis on the pre-intervention echocardiogram) will be excluded because hypo/akinesis would affect our endpoints of LV mass and diastolic function.
- Subjects who are unstable, not able to lie flat for the imaging studies, unable to give informed consent, pregnant, lactating, with atrial fibrillation (which would compromise measurement of E'), or current smokers will be excluded.
- Subjects with other major systemic diseases per their clinical charts, history, physical exam, or significant renal insufficiency will also be excluded, as these other system diseases may affect our study endpoints and subject follow-up.
- We will exclude patients with significant LV systolic dysfunction (ejection fraction <45%)
- We will not exclude patients with sleep apnea because it does not detrimentally affect LV diastolic function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiac function
Time frame: 2 weeks
cardiac function as measured by echocardiography incl. tissue Doppler
3 secondary outcomes
liver steatosis
Time frame: 2 weeks
myocardial steatosis
Time frame: 2 weeks
lipidomics
Time frame: 2 weeks
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 11 Jan 2024.
- Derived from this study: PubMed 26652763Airhart S, Cade WT, Jiang H, Coggan AR, Racette SB, Korenblat K, Spearie CA, Waller S, O'Connor R, Bashir A, Ory DS, Schaffer JE, Novak E, Farmer M, Waggoner AD, Davila-Roman VG, Javidan-Nejad C, Peterson LR. A Diet Rich in Medium-Chain Fatty Acids Improves Systolic Function and Alters the Lipidomic Profile in Patients With Type 2 Diabetes: A Pilot Study. J Clin Endocrinol Metab. 2016 Feb;101(2):504-12. doi: 10.1210/jc.2015-3292. Epub 2015 Dec 10.
Related trials for T2DM (Type 2 Diabetes Mellitus)
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Not yet recruiting
Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes Mellitus
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
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.
Linda R Peterson, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T2DM (Type 2 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 3 inclusion and 6 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 11 Jan 2024. 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?
cardiac function (time frame: 2 weeks). 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 NCT01373814, 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 11 Jan 2024.