Type 2 DiabetesCHO-free dietNCT01469104
Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes
A study testing 3 day fast and 3 day CHO-free diet in people with Type 2 Diabetes, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results in a change in blood glucose that is similar to the change observed after 3 days of fasting. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- 3 day fast and 3 day CHO-free diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2010
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- C-peptide > 1.5 ng/ml
Who cannot join
- Body mass index > 40
- hematological abnormalities
- liver disease
- kidney disease
- congestive heart failure
- life threatening malignancies
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
About this study
The investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results in a change in blood glucose that is similar to the change observed after 3 days of fasting.
Read the detailed description
In addition to plasma glucose concentrations, other hormones and metabolites known to be affected by fasting will be measured. These include insulin and glucagon, which are hormones that have an important role in regulating fuel use in the body.
- Conditions
- Type 2 Diabetes
- Being tested
- 3 day fast, 3 day CHO-free diet
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 day fastOther
Also called 3-Day Fast
Subjects will fast for 72 hours
3 day CHO-free dietOther
Also called Carbohydrate-free diet
Subjects will receive a carbohydrate-free diet for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| 3 day fast | Placebo comparator | After receiving a standard diet on day 1, subject will fast on days 2, 3, and 4. Water and calorie-fee beverages will be allowed during this 72 hour period. Receives: Other: 3 day fast |
| CHO-free diet | Active comparator | After receiving a standard diet on day 1, a carbohydrate-free diet will be provided on days 2, 3, and 4. Receives: Other: 3 day CHO-free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma glucose concentration
Measured: 24 hour profile:before and after meals, or traditional meal times
Secondary outcomes (1)
Change in serum insulin concentrations
Measured: 24 hour profiles: before and after meals or traditional meal times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startAug 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center
- Investigators
- Frank Q. Nuttall, M.D., Ph.D., Principal investigator, Minneapolis Veterans Affairs Medical CenterMary C. Gannon, Ph.D., Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469104
- Sponsor's protocol ID
- 4177
- Acronym
- CHO-free diet
- Status last verified
- Nov 2011
- First submitted
- 8 Nov 2011
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nuttall FQ, Almokayyad RM, Gannon MC. The ghrelin and leptin responses to short-term starvation vs a carbohydrate-free diet in men with type 2 diabetes; a controlled, cross-over design study. Nutr Metab (Lond). 2016 Jul 22;13:47. doi: 10.1186/s12986-016-0106-x. eCollection 2016.
PubMed 27453716Nuttall FQ, Almokayyad RM, Gannon MC. Comparison of a carbohydrate-free diet vs. fasting on plasma glucose, insulin and glucagon in type 2 diabetes. Metabolism. 2015 Feb;64(2):253-62. doi: 10.1016/j.metabol.2014.10.004. Epub 2014 Oct 8.
PubMed 25458830
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01469104
- Acronym / sponsor ID
- CHO-free diet / 4177
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Study start
- Aug 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Nov 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 investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results in a change in blood glucose that is similar to the change observed after 3 days of fasting.
Detailed description
In addition to plasma glucose concentrations, other hormones and metabolites known to be affected by fasting will be measured. These include insulin and glucagon, which are hormones that have an important role in regulating fuel use in the body.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 day fast | Placebo comparator | Other: 3 day fastAfter receiving a standard diet on day 1, subject will fast on days 2, 3, and 4. Water and calorie-fee beverages will be allowed during this 72 hour period. |
| CHO-free diet | Active comparator | Other: 3 day CHO-free dietAfter receiving a standard diet on day 1, a carbohydrate-free diet will be provided on days 2, 3, and 4. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes
- C-peptide > 1.5 ng/ml
Key exclusion criteria (6 listed)
- Body mass index > 40
- hematological abnormalities
- liver disease
- kidney disease
- congestive heart failure
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 |
|---|---|---|
| 3 day fastAlso: 3-Day FastSubjects will fast for 72 hours | Other | 3 day fast |
| 3 day CHO-free dietAlso: Carbohydrate-free dietSubjects will receive a carbohydrate-free diet for 72 hours | Other | CHO-free diet |
Primary outcome
Change in plasma glucose concentration
Time frame: 24 hour profile:before and after meals, or traditional meal times
1 secondary outcome
Change in serum insulin concentrations
Time frame: 24 hour profiles: before and after meals or traditional meal times
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 10 Nov 2011.
- Derived from this study: PubMed 27453716Nuttall FQ, Almokayyad RM, Gannon MC. The ghrelin and leptin responses to short-term starvation vs a carbohydrate-free diet in men with type 2 diabetes; a controlled, cross-over design study. Nutr Metab (Lond). 2016 Jul 22;13:47. doi: 10.1186/s12986-016-0106-x. eCollection 2016.
- Derived from this study: PubMed 25458830Nuttall FQ, Almokayyad RM, Gannon MC. Comparison of a carbohydrate-free diet vs. fasting on plasma glucose, insulin and glucagon in type 2 diabetes. Metabolism. 2015 Feb;64(2):253-62. doi: 10.1016/j.metabol.2014.10.004. Epub 2014 Oct 8.
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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.
Frank Q. Nuttall, M.D., Ph.D. principal investigator
Minneapolis Veterans Affairs Medical Center
Mary C. Gannon, Ph.D. principal investigator
Minneapolis Veterans Affairs 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 3 day fast and 3 day CHO-free diet in people with Type 2 Diabetes, run by Minneapolis Veterans Affairs 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 2 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 10 Nov 2011. 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?
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 plasma glucose concentration (time frame: 24 hour profile:before and after meals, or traditional meal times). 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 NCT01469104, which also lists 2 linked publications.
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 10 Nov 2011.