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Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes (CHO-free diet)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01469104
First received: November 8, 2011
Last updated: November 9, 2011
Last verified: November 2011
History of Changes

November 8, 2011
November 9, 2011
August 2009
June 2010   (final data collection date for primary outcome measure)
Change in plasma glucose concentration [ Time Frame: 24 hour profile:before and after meals, or traditional meal times ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01469104 on ClinicalTrials.gov Archive Site
Change in serum insulin concentrations [ Time Frame: 24 hour profiles: before and after meals or traditional meal times ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes
Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Type 2 Diabetes
  • Other: 3 day fast
    Subjects will fast for 72 hours
    Other Name: 3-Day Fast
  • Other: 3 day CHO-free diet
    Subjects will receive a carbohydrate-free diet for 72 hours
    Other Name: Carbohydrate-free diet
  • 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.
    Intervention: Other: 3 day fast
  • 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.
    Intervention: Other: 3 day CHO-free diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01469104
4177
No
Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center
Minneapolis Veterans Affairs Medical Center
Not Provided
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
Minneapolis Veterans Affairs Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP