Pizza Leavening and Postprandial Glycemia in Type 1 Diabetes (LEAVEN)

NCT03619031 | Completed

• 1 other identifier: 107/18
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare in patients with type 1 diabetes the postprandial glucose response to the consumption of three types of pizza, obtained with different leavening techniques. The intervention will be preceded by a one-week run-in period during which participants will undergo continuous glucose monitoring (CGM) to optimize basal infusion rate and insulin-to-glycemic load ratio. According to a randomized crossover design, the participants will consume at home at dinner-time in three different days over a 3-week period in random order: 1) a long-leavened pizza, composed of sourdough and a flour mix; 2) a short-leavened pizza, composed of sourdough and a flour mix; 3) a traditional pizza, composed of brewer's yeast and refined wheat flour, used as control. Over the three experimental weeks, participants will undergo CGM, wearing their sensors 7 days/week. The results of this study will allow optimizing insulin therapy based on the different characteristics of pizza in patients with type 1 diabetes mellitus treated with insulin pump. This will improve glycemic control and quality of life of these patients and reduce their risk of developing chronic diabetes complications.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; postprandial glycemia; pizza leavening

Outcome Measures

Primary Outcomes (2)

• Postprandial glucose response (AUC)

  Area under the curve

  2 hours

• Postprandial glucose response (AUC)

  Area under the curve

  8 hours

Secondary Outcomes (2)

• Blood glucose peak

  8 hours

• Time to blood glucose peak

  8 hours

Study Arms (3)

LONG LEAVENING

EXPERIMENTAL

Acute test meal

Other: LONG LEAVENING

SHORT LEAVENING

EXPERIMENTAL

Acute test meal

Other: SHORT LEAVENING

TRADITIONAL

ACTIVE COMPARATOR

Acute test meal

Other: TRADITIONAL

Interventions

LONG LEAVENING OTHER

a long-leavened (60 h) pizza composed of sourdough and a flour mix.

LONG LEAVENING

SHORT LEAVENING OTHER

a short-leavened (5 h) pizza composed of sourdough and a flour mix.

SHORT LEAVENING

TRADITIONAL OTHER

a short-leavened (5 h) pizza composed of brewer's yeast and 00 flour.

TRADITIONAL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment with continuous subcutaneous insulin infusion for at least 6 months
• HbA1c less than 8.0% (64 mmol/mol)

You may not qualify if:

• Pregnancy
• Celiac disease
• Serious microvascular and macrovascular diabetes complications including autonomic neuropathy possibly influencing gastric emptying
• Any other chronic or acute disease apart diabetes seriously affecting health status

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Clinical Medicine and Surgery

Naples, 80131, Italy

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 7, 2018
• Study Start: May 3, 2018
• Primary Completion: August 30, 2018
• Study Completion: September 15, 2018
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)