Type 1 DiabetesNCT01292590
Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes
A study testing High fat meal in people with Type 1 Diabetes, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if dietary fat alters insulin requirements in type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- High fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2011
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 1 diabetes using insulin pump and CGM
Who cannot join
- renal or hepatic failure
- cancer or lymphoma
- malabsorption or malnourishment
- hypercortisolism
- alcoholism or drug abuse
- anemia (hematocrit < 36 in females and <40 in males)
Show all 11Show fewer
- eating disorder
- dietary restrictions
- Acetaminophen allergy
- Chronic acetaminophen use
- Glucocorticoid therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Use of Closed Loop Control to Examine the Effect of Changes in Dietary Fat Intake on Insulin Requirements and Glucose Control
The purpose of this study is to determine if dietary fat alters insulin requirements in type 1 diabetes.
Read the detailed description
This cross-over prospective study will require a two day admission to the clinical research center. Subjects will undergo closed loop glucose control and will received a diet with controlled macronutrient content.
- Conditions
- Type 1 Diabetes
- Being tested
- High fat meal
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat mealOther
Also called Macronutrient
40 grams saturated fat
| Study group | Role | What they receive |
|---|---|---|
| High fat meal | Experimental | Not described Receives: Other: High fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin requirements
Measured: postprandially until 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor
- Investigators
- Howard Wolpert, MD, Principal investigator, Joslin Diabetes Center/Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292590
- Sponsor's protocol ID
- 2010-P-000140/1; BIDMC
- Status last verified
- Apr 2017
- First submitted
- 21 Oct 2010
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Closed Loop Control to Examine the Effect of Changes in Dietary Fat Intake on Insulin Requirements and Glucose Control
- ClinicalTrials.gov ID
- NCT01292590
- Acronym / sponsor ID
- 2010-P-000140/1; BIDMC
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Feb 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 purpose of this study is to determine if dietary fat alters insulin requirements in type 1 diabetes.
Detailed description
This cross-over prospective study will require a two day admission to the clinical research center. Subjects will undergo closed loop glucose control and will received a diet with controlled macronutrient content.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High fat meal | Experimental | Other: High fat meal |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- type 1 diabetes using insulin pump and CGM
Key exclusion criteria (11 listed)
- renal or hepatic failure
- cancer or lymphoma
- malabsorption or malnourishment
- hypercortisolism
- alcoholism or drug abuse
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 |
|---|---|---|
| High fat mealAlso: Macronutrient40 grams saturated fat | Other | High fat meal |
Primary outcome
Change in insulin requirements
Time frame: postprandially until 8 hours
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 26 Apr 2017.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Howard Wolpert, MD principal investigator
Joslin Diabetes Center/Beth Israel Deaconess 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 High fat meal in people with Type 1 Diabetes, run by Joslin Diabetes 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 1 inclusion and 11 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 26 Apr 2017. 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?
Change in insulin requirements (time frame: postprandially until 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2017.