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Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes

NCT ID: NCT01469104

Last Updated: 2011-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

3 day fast

Intervention Type OTHER

Subjects will fast for 72 hours

CHO-free diet

After receiving a standard diet on day 1, a carbohydrate-free diet will be provided on days 2, 3, and 4.

Group Type ACTIVE_COMPARATOR

3 day CHO-free diet

Intervention Type OTHER

Subjects will receive a carbohydrate-free diet for 72 hours

Interventions

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3 day fast

Subjects will fast for 72 hours

Intervention Type OTHER

3 day CHO-free diet

Subjects will receive a carbohydrate-free diet for 72 hours

Intervention Type OTHER

Other Intervention Names

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3-Day Fast Carbohydrate-free diet

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Frank Q. Nuttall, MD, PhD

Chief, Endocrinology, Metabolism & Nutrition Section, Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank Q. Nuttall, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Mary C. Gannon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Locations

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Minneapolis VA Health Care System

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27453716 (View on PubMed)

Nuttall 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.

Reference Type DERIVED
PMID: 25458830 (View on PubMed)

Other Identifiers

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4177

Identifier Type: -

Identifier Source: org_study_id