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High-Protein Diets and Diabetes (HPD)

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
University of Exeter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 40-70 y Body-mass index of 27-45 kg/m2 Diagnosed with T2D with their most recent HbA1c value greater than 6.0% (>43 mmol/mol) and receiving dietary advice and/or antidiabetic medication (metformin, DPP-4 inhibitors only). Males and females Exclusion Criteria: Habitual dietary intake of <0.6 or >1.2 g/kg/day protein (determined from dietary history interview given at screening) Current use of insulin HbA1c of 12% or more (≥108 mmol/mol) Weight loss of more than 5 kg within the past 6 months A recent estimated glomerular filtration rate (eGFR) of less than 30 mL/min, Heart failure, Participation in another clinical research trial, substance abuse, known cancer, myocardial infarction within the previous 6 months, current treatment with anti-obesity drugs, pregnancy or consideration of pregnancy, and hospital admission for depression or use of antipsychotic drugs.

Sites / Locations

  • Nutritional Physiology Research UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Animal

Non-animal

Arm Description

Arm of the study consuming a high-protein diet from animal sources.

Arm of the study consuming a high-protein diet from non-animal sources.

Outcomes

Primary Outcome Measures

Insulin sensitivity
Rate of disappearance (Rd) during the hyperinsulinaemic-euglycaemic clamp from participants on each diet, a measure of insulin sensitivity.

Secondary Outcome Measures

β-cell function
β-cell function measured by modelling of glucose, insulin and c-peptide during MMTT
Glucose control
Glucose control measured by fasting glucose, 2 hour MMTT glucose, 24-hour glucose profile using continuous glucose monitoring probe and HbA1c.
Branched-chain amino acid (BCAA) metabolism
BCAA metabolism measured by plasma BCAA concentration.
Diabetes treatment satisfaction measured by the diabetes treatment satisfaction questionnaire
Treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ).

Full Information

First Posted
May 26, 2022
Last Updated
November 7, 2022
Sponsor
University of Exeter
Collaborators
Marlow Foods Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05615558
Brief Title
High-Protein Diets and Diabetes
Acronym
HPD
Official Title
The Impact of a High-Protein Diet From Animal vs. Non-Animal Sources on Insulin Sensitivity and β-cell Function in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Exeter
Collaborators
Marlow Foods Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
High-protein (HP) diets are popular and evidence indicates they are more likely to be adhered to and produce more sustained weight loss, particularly under ad libitum conditions. They also improve glucose control and so may be helpful for treatment of Type 2 Diabetes (T2D), particularly in the short-term, possibly via an improvement in insulin secretion. Indeed, HP diets may be uniquely effective at promoting insulin secretion in T2D, but further research is needed to understand why HP. Thus, there is an urgent need to determine how HP diets affect T2D pathophysiology of insulin secretion and action using direct measures of β-cell dysfunction and insulin sensitivity. It is also imperative to know how the type of protein (animal vs. non-animal) affects insulin secretion in order to ultimately obtain an environmentally and economically sustainable HP diet that can improve glucose control and T2D pathophysiology in the long-term as well as providing patients with a greater choice for dietary management of T2D.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Animal
Arm Type
Experimental
Arm Description
Arm of the study consuming a high-protein diet from animal sources.
Arm Title
Non-animal
Arm Type
Experimental
Arm Description
Arm of the study consuming a high-protein diet from non-animal sources.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
Controlled dietary intervention; all food is provided to participants after being allocated to animal or non-animal dietary protein, for a duration of 5 weeks.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Rate of disappearance (Rd) during the hyperinsulinaemic-euglycaemic clamp from participants on each diet, a measure of insulin sensitivity.
Time Frame
Change from Baseline insulin sensitivity after 5-week controlled diet
Secondary Outcome Measure Information:
Title
β-cell function
Description
β-cell function measured by modelling of glucose, insulin and c-peptide during MMTT
Time Frame
Change from Baseline β-cell function after 5-week controlled diet
Title
Glucose control
Description
Glucose control measured by fasting glucose, 2 hour MMTT glucose, 24-hour glucose profile using continuous glucose monitoring probe and HbA1c.
Time Frame
Change from Baseline glucose control after 5-week controlled diet
Title
Branched-chain amino acid (BCAA) metabolism
Description
BCAA metabolism measured by plasma BCAA concentration.
Time Frame
Change from Baseline BCAA after 1, 2, 3, 4 and 5 weeks of controlled diet
Title
Diabetes treatment satisfaction measured by the diabetes treatment satisfaction questionnaire
Description
Treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ).
Time Frame
Change from Baseline treatment satisfaction after 5-week controlled diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 40-70 y Body-mass index of 27-45 kg/m2 Diagnosed with T2D with their most recent HbA1c value greater than 6.0% (>43 mmol/mol) and receiving dietary advice and/or antidiabetic medication (metformin, DPP-4 inhibitors only). Males and females Exclusion Criteria: Habitual dietary intake of <0.6 or >1.2 g/kg/day protein (determined from dietary history interview given at screening) Current use of insulin HbA1c of 12% or more (≥108 mmol/mol) Weight loss of more than 5 kg within the past 6 months A recent estimated glomerular filtration rate (eGFR) of less than 30 mL/min, Heart failure, Participation in another clinical research trial, substance abuse, known cancer, myocardial infarction within the previous 6 months, current treatment with anti-obesity drugs, pregnancy or consideration of pregnancy, and hospital admission for depression or use of antipsychotic drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gráinne Whelehan, BSc.
Phone
013922157
Email
g.whelehan@exeter.ac.uk
Facility Information:
Facility Name
Nutritional Physiology Research Unit
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX12LU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gráinne Whelehan, BSc.
Phone
013922157
Email
g.whelehan@exeter.ac.uk

12. IPD Sharing Statement

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High-Protein Diets and Diabetes

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