Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes
CHO-free diet
1 other identifier
interventional
7
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Aug 2009
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 8, 2011
CompletedFirst Posted
Study publicly available on registry
November 10, 2011
CompletedNovember 10, 2011
November 1, 2011
10 months
November 8, 2011
November 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in plasma glucose concentration
24 hour profile:before and after meals, or traditional meal times
Secondary Outcomes (1)
Change in serum insulin concentrations
24 hour profiles: before and after meals or traditional meal times
Study Arms (2)
3 day fast
PLACEBO COMPARATORAfter 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 COMPARATORAfter receiving a standard diet on day 1, a carbohydrate-free diet will be provided on days 2, 3, and 4.
Interventions
Subjects will receive a carbohydrate-free diet for 72 hours
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- C-peptide \> 1.5 ng/ml
You may not qualify if:
- Body mass index \> 40
- hematological abnormalities
- liver disease
- kidney disease
- congestive heart failure
- life threatening malignancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
Related Publications (2)
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.
PMID: 27453716DERIVEDNuttall 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.
PMID: 25458830DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Q. Nuttall, M.D., Ph.D.
Minneapolis Veterans Affairs Medical Center
- PRINCIPAL INVESTIGATOR
Mary C. Gannon, Ph.D.
Minneapolis Veterans Affairs Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Endocrinology, Metabolism & Nutrition Section, Professor of Medicine
Study Record Dates
First Submitted
November 8, 2011
First Posted
November 10, 2011
Study Start
August 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
November 10, 2011
Record last verified: 2011-11