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Almond Intervention in Type 2 Diabetes Mellitus

Primary Purpose

Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
almond
Sponsored by
Diabetes Foundation, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients in the age range of 25-65 years
  • on stable doses of metformin from past 3 months
  • having HbA1C less than 9%
  • LDL-c ≥100 mg/dl were recruited

Exclusion Criteria:

  • Patients on insulin therapy, plioglitazone, insulin secretagogues, beta blockers or steroids or suffering from diabetes for more than 10 years
  • having high uric acid levels (≥ 8 mg/dl),
  • with accelerated hypertension (stage 2 hypertension according to JNC guidelines) , hypothyroidism, suffering from acute infection or any debilitating disease or with renal failure,
  • appreciable weight loss (more than 10%) during past 6 months
  • Patients with known food allergy, lipid altering medication or extraneous factors that can affect glycemic or lipid parameters

Sites / Locations

  • Fortis Flt Lt Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

almond

Arm Description

almonds are substituted for visible fat and carbohydrates

Outcomes

Primary Outcome Measures

Change in LDL-c

Secondary Outcome Measures

HbA1C

Full Information

First Posted
January 3, 2014
Last Updated
January 3, 2014
Sponsor
Diabetes Foundation, India
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1. Study Identification

Unique Protocol Identification Number
NCT02027740
Brief Title
Almond Intervention in Type 2 Diabetes Mellitus
Official Title
Effect of Almond Supplementation on Glycemic and Cardiovascular Risk Factors in Asian Indians in North India With Type 2 Diabetes Mellitus: A 24-week Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diabetes Foundation, India

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This prospective cohort study of an almond-enriched diet (within the overall context of Asian Indian dietary guidelines) was conducted to test the hypothesis that in patients with T2DM almond-enriched balanced diet improves glycemic measures and CVD risk factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
almond
Arm Type
Experimental
Arm Description
almonds are substituted for visible fat and carbohydrates
Intervention Type
Dietary Supplement
Intervention Name(s)
almond
Primary Outcome Measure Information:
Title
Change in LDL-c
Time Frame
baseline, after six months
Secondary Outcome Measure Information:
Title
HbA1C
Time Frame
baseline, after six months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients in the age range of 25-65 years on stable doses of metformin from past 3 months having HbA1C less than 9% LDL-c ≥100 mg/dl were recruited Exclusion Criteria: Patients on insulin therapy, plioglitazone, insulin secretagogues, beta blockers or steroids or suffering from diabetes for more than 10 years having high uric acid levels (≥ 8 mg/dl), with accelerated hypertension (stage 2 hypertension according to JNC guidelines) , hypothyroidism, suffering from acute infection or any debilitating disease or with renal failure, appreciable weight loss (more than 10%) during past 6 months Patients with known food allergy, lipid altering medication or extraneous factors that can affect glycemic or lipid parameters
Facility Information:
Facility Name
Fortis Flt Lt Hospital
City
Delhi
Country
India

12. IPD Sharing Statement

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Almond Intervention in Type 2 Diabetes Mellitus

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