NCT01247714

Brief Summary

The hypothesis of the proposed trials is that the regular intake of a specific diet designed for enteral nutrition of type 2 diabetic patients results into a better nutritional status. Thus, the aim of the study is to scientifically evaluate the healthy effects of the administration of an enteral complete diet for diabetic patients (T-Diet plus Diabet).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 10, 2014

Status Verified

November 1, 2010

Enrollment Period

5.3 years

First QC Date

November 23, 2010

Last Update Submit

December 9, 2014

Conditions

HyperglycemiaDiabeticsMetabolic Syndrome

Keywords

T-Diet plus Diabet NPDiabeticEnteral NutritionGlycaemic responseMetabolic SyndromeInsulin resistanceLipidic profile

Outcome Measures

Primary Outcomes (1)

  • Nutritional status and Glycaemia

    * Evaluation of the nutritional status of diabetic patients fed the T-Diet Plus Diabet NP in comparison with the reference and the control diet. * Evaluation of glycaemia and glycosylated hemoglobin

    9 months

Secondary Outcomes (1)

  • Biochemicals parameters measure

    9 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

The group 1 will receive the experimental product T-Diet plus Diabet NP for the first month followed by a reference diet corresponding to a current marketed product (Glucerna SR, Abbott) for the second month, then the patients will receive a control product non specific for diabetic patients (T-Diet plus Standard)for the third month, and finally a specific diet for diabetic patients (Novasource, Nestlé Healthcare Nutrition)for the fourth month.

Dietary Supplement: T-Diet plus StandardDietary Supplement: T-Diet plus Diabet NPDietary Supplement: GlucernaDietary Supplement: Novasource

Group 2

ACTIVE COMPARATOR

The group 2 will receive a reference diet corresponding to a current marketed product (Glucerna SR, Abbott)for the first month, followed by the experimental product T-Diet plus Diabet NP for the second month, then the patients will receive a specific diet for diabetic patients (Novasource, Nestlé Healthcare Nutrition)for the third month, and finally a control product non specific for diabetic patients (T-Diet plus Standard)for the fourth month

Dietary Supplement: T-Diet plus StandardDietary Supplement: T-Diet plus Diabet NPDietary Supplement: GlucernaDietary Supplement: Novasource

Interventions

T-Diet plus StandardDIETARY_SUPPLEMENT

T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.

Also known as: PLUS STD
Group 1Group 2
T-Diet plus Diabet NPDIETARY_SUPPLEMENT

T-Diet plus Diabet NP is a complete balanced oral nutrition supplement, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.

Also known as: DIABET NP
Group 1Group 2
GlucernaDIETARY_SUPPLEMENT

GLUCERNA 1.0 CAL is a reduced-carbohydrate, modified-fat, fiber-containing formula clinically shown to blunt blood-glucose response in patients with abnormal glucose tolerance.

Also known as: GLCR
Group 1Group 2
NovasourceDIETARY_SUPPLEMENT

Complete high protein diet for diabetic patients and hyperglycemic

Also known as: NVS
Group 1Group 2

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic Subjects older than 55 years.
  • Male or female
  • Requirement of total enteral nutrition (TEN) during at least 3 months.
  • Under medical supervision.
  • Voluntary informed consent for participation.

You may not qualify if:

  • Unstable clinical situation
  • Fatal illness
  • Patients treated with lipidic drugs
  • Refusal to participate in the study or being enrolled in other clinical trials.
  • Social or humanitarian reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biochemistry and Molecular Biology II. University of Granada

Granada, Granada, 18014, Spain

Location

MeSH Terms

Conditions

HyperglycemiaMetabolic SyndromeInsulin Resistance

Interventions

PhentermineGlucerna

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Ángel Gil, PhD

    Departament of Biochemistry and Molecular Biology II. University of Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 24, 2010

Study Start

September 1, 2009

Primary Completion

December 1, 2014

Study Completion

May 1, 2015

Last Updated

December 10, 2014

Record last verified: 2010-11

Locations

ES(1)