Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes (CHO-free diet)
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ClinicalTrials.gov Identifier: NCT01469104 |
Recruitment Status
:
Completed
First Posted
: November 10, 2011
Last Update Posted
: November 10, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Other: 3 day fast Other: 3 day CHO-free diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 3 day fast
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.
|
Other: 3 day fast
Subjects will fast for 72 hours
Other Name: 3-Day Fast
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Active Comparator: CHO-free diet
After receiving a standard diet on day 1, a carbohydrate-free diet will be provided on days 2, 3, and 4.
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Other: 3 day CHO-free diet
Subjects will receive a carbohydrate-free diet for 72 hours
Other Name: Carbohydrate-free diet
|
- Change in plasma glucose concentration [ Time Frame: 24 hour profile:before and after meals, or traditional meal times ]
- Change in serum insulin concentrations [ Time Frame: 24 hour profiles: before and after meals or traditional meal times ]

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Ages Eligible for Study: | 45 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 2 diabetes
- C-peptide > 1.5 ng/ml
Exclusion Criteria:
- Body mass index > 40
- hematological abnormalities
- liver disease
- kidney disease
- congestive heart failure
- life threatening malignancies

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469104
United States, Minnesota | |
Minneapolis VA Health Care System | |
Minneapolis, Minnesota, United States, 55417 |
Principal Investigator: | Frank Q. Nuttall, M.D., Ph.D. | Minneapolis VA Health Care System | |
Principal Investigator: | Mary C. Gannon, Ph.D. | Minneapolis VA Health Care System |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Frank Q. Nuttall, MD, PhD, Chief, Endocrinology, Metabolism & Nutrition Section, Professor of Medicine, Minneapolis Veterans Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT01469104 History of Changes |
Other Study ID Numbers: |
4177 |
First Posted: | November 10, 2011 Key Record Dates |
Last Update Posted: | November 10, 2011 |
Last Verified: | November 2011 |
Keywords provided by Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center:
Diabetes |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |