| Eligibility |
Inclusion Criteria:
- 18-75 years of age (if >65 years of age, enrolment at the discretion of qualified
investigator)
- BMI 27-60 Kg/m2
- Stable Type 2 diabetes mellitus (i.e. no medication change in the last 3 months)
- Ability to provide written informed consent in accordance with Good Clinical Practice
(GCP) and local legislation
Exclusion Criteria:
- HbA1c <7.0% or >10.0%
- History of any bariatric surgery
- >10 Kg weight gain or weight loss in the past 3 months
- Known eating disorder
- Participant has taken weight loss medication in the last 3 months (eg. Meridia,
Xenical)
- Participant is taking any of the following medications that can alter body weight or
appetite:
- Antipsychotics or neuroleptics
- Prednisone
- Antidepressants
- Tricyclic such as amitriptyline, imipramine (Tofranil), and doxepin
(Sinequan)
- Monoamine oxidase inhibitors (MAOIs) such as tranylcypromine, (Parnate),
isocarboxazid (Marplan) and phenelzine (Nardil)
- Tetracyclic such as Mirtazapine (Remeron)
- Serotonin antagonist and reuptake inhibitors (SARI) such as Trazodone
Note: The following antidepressants are NOT exclusion medications:
- SSRIs such as citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox),
fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil)
- Wellbutrin
- SNRIs such as venlafaxine (Effexor), duloxetine (Cymbalta)
- Participant is taking any of the following natural health products that can alter
body weight or appetite: ephedra, synephrine, green tea extracts, daily use of
bulk fibre laxatives (e.g. psyllium, glucomannan)
- Participant not eligible for enrolment in a medically supervised LCD program at
the Wharton Medical Clinic (WMC only accepts patients by referral from a family
physician. To be eligible patients must have a BMI = 30 or = 27 with at least one
obesity related comorbidity.)
- Patient with a past history of severe hypoglycaemia (as defined by the Diabetes
Control and Complications Trial (DCCT)) whether or not on insulin, sulfonylureas
and non-sulfonylurea secretogogues
- Patient with documented hypoglycemic unawareness, whether or not on insulin,
sulfonylureas and non-sulfonylurea secretogogues
- Achalasia (i.e. difficulty swallowing)
- Patient is taking medication that targets GLP-1 (glucagon-like peptide-1)
including GLP-1 analogues (e.g. Byetta (Exenatide), Victoza (Liraglutide)) and
DPP-IV inhibitors (e.g. Januvia(Sitagliptin), Onglyza (Saxagliptin).
- Positive urine pregnancy test, pregnancy, breast feeding, or hormonal
contraceptives started in the last 6 months prior to the start of the study
- Absence of a highly effective method of birth control for female of childbearing
potential (premenopausal or not surgically sterile) OR does not plan to use
contraception for the duration of study participation AND does not agree to
periodic urine pregnancy testing during the study. ICH M3 defines a highly
effective method of birth control as those which result in a low failure rate
(i.e. less than 1% per year) when used consistently and correctly such as
implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence
or vasectomised partner.
- Substance abuse: tobacco (including those who have quit smoking in the last 12
months), Cannabis sativa, or other controlled substances use
- Any allergies to study product ingredients including dairy, whey, rice, soy and
or coconut.
- Labile or uncontrolled hypertension (SBP = 160 mmHg and/or DBP = 100 mmHg)
- Current diagnosis or history of gastrointestinal diseases or disorders (with the
exception of Irritable Bowel Syndrome and GERD at the discretion of qualified
investigator).
- Heart failure
- Substantial neurological or psychological illness within the last 6 months (at
the discretion of qualified investigator)
- Contraindications to LCD
1. any major surgery that is, at the time of screening, planned to take place
during the study
2. history of drug or alcohol dependency within six months prior to signing the
informed consent form.
3. history of active malignancy (exceptions at the discretion of qualified
investigator e.g. squamous cell carcinoma), chronic inflammatory disorder,
or chronic infections which would interfere with protocol completion
4. history of CV event or angina within 6 months (with the exception of stable
angina at the discretion of qualified investigator)
5. history of active gall bladder disease where the gallbladder was not removed
6. inflammatory bowel disease
7. type 1 diabetes
8. significant renal impairment eGFR < 50
9. porphyria
10. cirrhosis
11. patients deemed unable to comprehend or comply with the diet and/or,
12. unable to attend program follow up visits
- Participant cannot fully understand all instructions in English.
- Any other medical, social or geographic condition, which, in the opinion of the
qualified investigator would not allow safe completion of the protocol.
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