A Clinical Study to Investigate and Compare the Impact of High Protein Pasta, Lower Protein Pasta and White Rice on Blood Sugar Control in People With Type 1 Diabetes Mellitus (T1DM)

NCT03362151 | Completed

• 1 other identifier: IRB17-1316
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical study is to investigate and compare the postprandial glycemic response to three different meal types rich in carbohydrates, that is, white pasta, high protein pasta and white rice consumed by individuals with T1DM.

Conditions

Diabetes Mellitus, Type 1

Keywords

type 1 diabetes; pasta; rice; protein; carbohydrate

Outcome Measures

Primary Outcomes (1)

• Delta glucose (maximum rise from baseline glucose) mg/dL

  Delta glucose (maximum rise from baseline glucose) from the start of the meal to the peak continuous glucose monitoring (CGM) glucose reading (mg/dL) during the 5-hour postprandial window, compared between the three meal types.

  5 hours

Secondary Outcomes (3)

• Incremental area under the curve (area)

  5 hours

• Time to peak glucose level (minutes)

  5 hours

• percent time glucose <70 mg/dL

  5 hours

Study Arms (3)

Regular pasta

EXPERIMENTAL

Subjects will bolus rapid acting insulin per their carbohydrate ratio just prior to a meal of regular pasta. They will consume this meal on two separate occasions.

Other: Regular pasta

High protein pasta

EXPERIMENTAL

Subjects will bolus rapid acting insulin per their carbohydrate ratio just prior to a meal of high protein pasta. They will consume this meal on two separate occasions.

Other: High protein pasta

White rice

EXPERIMENTAL

Subjects will bolus rapid acting insulin per their carbohydrate ratio just prior to a meal of white rice. They will consume this meal on two separate occasions.

Other: White rice

Interventions

Regular pasta OTHER

Regular pasta (Approximately 42 grams carbohydrate per meal)

Regular pasta

High protein pasta OTHER

High protein pasta (Approximately 38 grams carbohydrate per meal)

High protein pasta

White rice OTHER

White rice (Approximately 43 grams carbohydrate per meal)

White rice

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 75 years at the time of screening.
• Clinical diagnosis of type 1 diabetes for at least one year.
• HbA1c ≤ 10%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
• Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes, and boluses for all meals and snacks that contain ≥ 5 grams of carbohydrate.
• Willing to refrain from taking acetaminophen products for the duration of the clinical trial. If acetaminophen is taken, subject is to avoid making any insulin dosing decisions based on CGM for at least 12 hours.
• For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile at the screening visit. Subjects who become pregnant will be discontinued from the study.
• Willing to abide by the study protocol and use study-provided devices.

You may not qualify if:

• Gastrointestinal disease such as celiac disease or multiple food allergies.
• Any form of gluten sensitivity or wheat allergy.
• Allergies to any form of nuts and ingredients present in the study meals (tomatoes etc).
• History of gastroparesis.
• Pregnancy.
• Dermatological conditions that would preclude wearing a CGM sensor.
• Screening A1c \> 10%.
• Any condition that could interfere with participating in the trial, based on the investigator's judgment.
• A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study.

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Harvard University: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Related Publications (1)

• Zavitsanou S, Massa J, Deshpande S, Pinsker JE, Church MM, Andre C, Doyle Iii FJ, Michelson A, Creason J, Dassau E, Eisenberg DM. The Effect of Two Types of Pasta Versus White Rice on Postprandial Blood Glucose Levels in Adults with Type 1 Diabetes: A Randomized Crossover Trial. Diabetes Technol Ther. 2019 Sep;21(9):485-492. doi: 10.1089/dia.2019.0109. Epub 2019 Jun 21.

  PMID: 31225739 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Eisenberg, MD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Eyal Dassau, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

• Jordan E Pinsker, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects will not be told which meal they are eating.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will consume pre-determined meals on 6 difference occasions. There will be three categories of "study meals" consisting of: 1. Regular pasta (42 grams carbohydrate per meal) 2. High protein pasta (38 grams carbohydrate per meal) 3. White rice (43 grams carbohydrate per meal) Each subject will consume each meal on two separate occasions in random order.

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: January 1, 2018
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)