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Completed

NCT Number: NCT01222429

Practice Based Nutrition Intervention

This study aims to test a dietary intervention for diabetes in a medical practice setting, with the aim of developing a model for diabetes care that can be used widely. The investigators hypothesize that a low-fat vegan diet will be effective for management of diabetes and will be feasible in a practice-based setting.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Specific Aim 1 tests the hypothesis that the nutrition intervention (low fat, low-GI vegan diet) improves glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in a within-group analysis.

Specific Aim 2 tests the hypothesis that the nutrition intervention (low fat, low-GI vegan diet) is more effective than standard nutrition care for improving glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in individuals with type 2 diabetes

Specific Aim 3 tests the hypothesis that a low-fat vegan diet is sustainable among individuals with type 2 diabetes for a 20-week period, with weekly classes, and in a follow-up period of one year with limited professional support.

Specific Aim 4 tests the hypothesis that a low-fat vegan diet has an acceptability that is comparable to that of standard nutrition care among individuals with type 2 diabetes.

Specific Aim 5 tests the hypothesis that the effects of the dietary interventions on A1c and body weight are reduced in individuals with the A1 allele of the Taq1A and Taq1B polymorphism

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥126 mg/dl on 2 occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least 6 months
  • male or female
  • A1c between 6.5% and 10.5%
  • age at least 18 years
  • ability and willingness to participate in all components of the study
  • willingness to be assigned to either a low-fat, vegan diet or to standard nutrition care
  • diabetes medications unchanged for 1 month prior to volunteering for the study
  • patient of Dr. Mark Sklar

Exclusion criteria

  • body mass index >45 kg/m2
  • alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
  • use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
  • pregnancy or plans to become pregnant
  • history of severe mental illness (with current unstable status)
  • likely to be disruptive in group sessions (as determined by research staff)
  • Signs/symptoms of acute uncontrolled diabetes (including but not limited to polyuria, polydipsia, blurred vision, uncontrolled weight loss)
  • unstable medical status
  • already following a low-fat, vegetarian diet
  • an inordinate fear of blood draws
  • inability to maintain current medication regimen
  • lack of English fluency

Treatment and study plan

Vegan Diet

Other

Intervention group participants will follow a low-fat vegan diet and will receive instruction on this diet through the course of the study

diet following ADA guidelines

Other

participants will be given instruction on the ADA guidelines for diabetes, and will follow an individualized plan based on these guidelines

Primary outcomes

  1. hemoglobin A1C (diabetes management)

    Time frame: assessment at baseline (0 weeks)

  2. hemoglobin A1C (diabetes management)

    Time frame: assessment at 10 weeks

  3. hemoglobin A1C (diabetes management)

    Time frame: assessment at 20 weeks

  4. hemoglobin A1C (diabetes management)

    Time frame: assessment at one-year follow-up

  5. lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)

    Time frame: assessment at baseline (0 weeks)

  6. lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)

    Time frame: assessment at 10 weeks

  7. lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)

    Time frame: assesment at 20 weeks

  8. lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)

    Time frame: assessment at one-year follow-up

  9. body weight

    Time frame: assessment at baseline (0 weeks)

  10. body weight

    Time frame: assessment at 10 weeks

  11. body weight

    Time frame: assessment at 20 weeks

  12. body weight

    Time frame: assessment at one-year follow-up

  13. indices of renal function (serum creatinine, microalbumin)

    Time frame: assessment at baseline (0 weeks)

  14. indices of renal function (serum creatinine, microalbumin)

    Time frame: assessment at 10 weeks

  15. indices of renal function (serum creatinine, microalbumin)

    Time frame: assessment at 20 weeks

  16. indices of renal function (serum creatinine, microalbumin)

    Time frame: assessment at one-year follow-up

Sponsors and collaborators

Lead sponsor

Physicians Committee for Responsible Medicine

Other

Registry information

Official study title

Practice-Based Nutrition Intervention

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 18, 2010
Registry last updated
Aug 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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