Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes (CHO-free diet)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes|
- Change in plasma glucose concentration [ Time Frame: 24 hour profile:before and after meals, or traditional meal times ] [ Designated as safety issue: No ]
- Change in serum insulin concentrations [ Time Frame: 24 hour profiles: before and after meals or traditional meal times ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
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
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.
Other: 3 day CHO-free diet
Subjects will receive a carbohydrate-free diet for 72 hours
Other Name: Carbohydrate-free diet
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|